Orthopaedic surgery involves a large assortment of tools, including drills like those seen on the right, used to bore holes in bones. (File photo)
A patient undergoing a double hip replacement had to be woken up with the job half done when moisture was seen on drill bits intended to bore holes in their bone.
According to official documents from Te Whatu Ora – Health NZ (HNZ), the incident is the only time sterilisation issues caused a surgery to be abandoned in Wellington hospitals in almost two-and-half years, but a hospital staffer claims there were others.
“[Surgical equipment] was coming back damp which is a sign it’s not properly sterilised, so we were cancelling cases because we couldn’t guarantee things were sterilised,” said the staffer, who Stuff agreed not to name in order to protect their job.
“There was a bit of a standing joke that Friday hip surgeries were jinxed after about three instances where the wrap on the instruments had been compromised.”
* ‘Debris’ from previous surgeries still on ‘sterilised’ surgical instruments * Steriliser that cleans surgical equipment in Hawke’s Bay Hospital was never turned on, review finds * Hospital sterilisation units are not audited by the Health Ministry but may be after Hawke’s Bay incident
Details provided under the Official Information Act revealed how the operation in January 2021 was stopped after one hip had been completed “due to a sterilisation issue with wet drill sets”.
MONIQUE FORD/Stuff
The incident was the only one the Capital, Coast and Hutt Valley Health NZ district found in two-and-a-half years that had been deferred due to sterilisation issues, but a staffer claims there were others. (File photo)
As a result, their second hip replacement was deferred four months till May 2021.
“On setting up for the second [hip replacement], all available drill sets were found to have had moisture,” director for the Capital, Coast and Hutt Valley district, Dr John Tait, said.
These drill sets all came from the same load, he said. The steriliser had been inspected and calibrated the week before the surgery.
STUFF
Health Minister Andrew Little talks to Stuff health reporter Rachel Thomas about pressures on the health system, nurses’ pay and how he intends to fix workforce shortages.
The incident was investigated and an inspection of the steriliser and metal instrument crates found steam was being trapped.
“A decision was made to transfer drills to a tray and surgical wrap system. The above actions addressed the issue,” Tait said.
Orthopaedic surgeries tend to use a lot of tools – so overloaded trays seemed to be causing the issue, the staffer said.
Simon Watts/Stuff
Tools go through sterilisers in metal crates like the one pictured above. If these trays are overloaded, it increased the chance of tools coming back damp, a hospital staffer says. (File photo)
The staffer agreed sterilisation issues were not ongoing – equipment upgrades and running drills through on their own had helped.
But they described another case more than two years ago at Kenepuru Hospital, where they were present.
“We got the patient into theatre and then they go: ‘Wait, stop, this stuff is still wet. We can’t use it.’”
When Capital & Coast was asked about this case in June, director of provider services Joy Farley said it could not find that particular incident, but stated sterilisation issues were not ongoing.
Simon Watts/Stuff
Daily audits are carried out on equipment, as well as regular preventative maintenance and vaildation on all sterilisers.
“However there are occasional occurrences of damp packs that can be caused by … issues related to tray packing, wrapping, or steriliser loading; steam supply issues; and environmental issues related to storage such as temperature and humidity,” Farley said.
“In the rare event that a damp pack or tray were identified, we have sufficient instruments to source a new set – and only on a very rare occasion would it be specialised instrumentation where a back-up set may not available.”
Along with daily audits of all equipment processing, regular preventative maintenance and validation was carried out on all sterilisers, Farley said.
“Standard checks are followed during the decontamination and sterilisation processes, and before the release of instruments for use in surgery.”
Theatre nurses also performed extra checks to ensure instruments were sterile, including checking for damp packs, which was in line with national standards, Farley said.
The mother of a four-year-old girl who has already spent years on a waiting list for a vital hip operation, said she fears the latest delays in complex scoliosis surgery in Temple St Hospital will push more children down the queue.
onya Boyce from Kilmacanogue, Co Wicklow, said her daughter Cara, who was born with spina bifida and is confined to a wheelchair, has had a dislocated hip since birth.
But although it should have been corrected before she was two, she still has no date for the surgery.
“Cara will be five later this month and starts junior infants class today with her dislocated hip and I still have no idea when the surgery will be carried out,” she said.
Her heart sank when she heard Temple Street Hospital is having to postpone planned operations on children who were ready to have complex scoliosis surgery over the next three weeks because of pressure on services.
The hospital said it had increased complex scoliosis surgeries since April but these children can need multiple follow-up operations with stays of as much as six months in some cases.
It needs to pause for three weeks to plan how it will manage these young patients going forward into autumn and winter.
Cara does not have scoliosis but she is among 52 children living with spina bifida and waiting for orthopaedic care in Temple Street who are languishing on waiting lists, said the Paediatric Advocacy Group — parents who have been campaigning for improvements in services.
Tonya said: “Cara is having to sit on a dipped seat in her wheelchair and is leaning to one side. It is uncomfortable and I see her changing positions. She is not getting the full benefit of her physiotherapy.
“She will have to sit for several hours in school. At some point when she gets the surgery, she will need to take time off school.”
Amanda Coughlan-Santry, co-lead of the Paediatric Advocacy Group, said she acknowledged the huge body of work done by frontline staff since families started the campaign to tackle waiting lists earlier this year.
However, she said her group had foreseen the kind of postponements now enforced unless there was a timely access for children to prevent post-operative complications, prolonged stays and readmissions.
She said the additional €19m in funding provided this year to make inroads in to waiting lists “has been spread too thinly across a range of spina bifida and scoliosis-related services and this is the knock-on effect.”
“Unfortunately efforts made by us to maintain engagement and highlight our concerns with Health Minister Stephen Donnelly have been met with silence,” she said. “When negative attention passes, so too does the promise of support.”
A spokeswoman for Temple Street said as of August 28, it had done the same number of spinal fusions year to date as were completed for the full year of 2021 — a total of 28.
Of 31 spinal fusion waiting list patients, 13 are complex. Non-complex spinal surgeries are continuing.
“We remain on track to deliver on the promise that by year end, no patient will be waiting longer than four months for spinal surgery – if clinically appropriate.”
However, Claire Cahill of the Scoliosis Advocacy Network said across the children’s hospitals, 258 children are waiting for scoliosis-related surgeries – a significant increase on the list of 187 last September.
Question: My dad is having hip replacement surgery soon and he’s worried about sleeping afterwards. He typically can only get comfortable on his side, and his worry about not being able to sleep is adding to his anxiety about the surgery. Is there a way he can sleep on his side after surgery without being uncomfortable? Or what would be the best sleeping position?
Answer: Sleeping comfortably after any invasive surgery can be difficult to say the least. Whether you’re a side, stomach or back sleeper, falling asleep and staying asleep can be uncomfortable—and many people become frustrated. These three points may help him find some priceless comfort and sleep:
1. Stay diligent with your hip precautions. Some pain and discomfort is inevitable for a while. Things can become much worse if your joint replacement is compromised, so stick with the precautions to avoid further complications.
2. Follow your surgeon’s pain management prescription, especially leading up to bedtime. Falling asleep is difficult enough when you aren’t able to assume your normal sleeping position. Take the edge off your pain by following your surgeon’s pain management plan.
3. For side sleepers: pillows, pillows, pillows! While lying on your nonsurgical side, use pillows between your knees to help avoid internal rotation at your hip. It’s best to also keep a pillow between your ankles as well. This will help to maintain alignment of your legs to avoid extra stress on your new joint and, most of all, avoid pain as much as possible.
Remember, your recovery is a short period of time in the broad scope of your lifetime. Invest in your future with patience, follow your surgeon’s instructions to a T, and restful sleep will come.
Prevalence of central sensitivity syndromes in patients with hip osteoarthritis before total hip arthroplasty
The number (prevalence) of patients with CSSs is shown in Table 1. Migraine or tension headaches; neck injury, including whiplash; depression; temporomandibular joint disorder; irritable bowel syndrome; anxiety or panic attacks; and FM were present in 8.0%, 7.4%, 5.7%, 5.1%, 1.7%, 1.1%, and 1.1% of patients, respectively. Additionally, 0.6% of patients had a history of restless leg syndrome, multiple chemical sensitivities, and chronic fatigue syndrome. Furthermore, 18.3%, 4.6%, 1.1%, and 0.6% of patients were diagnosed with 1–4 CSSs, respectively. After excluding patients with FM, 41 patients with one or more CSSs and 132 patients without CSSs were analyzed (Fig. 1). Demographic and clinical factors of patients with and without CSSs are shown in Table 2. The proportion of women was higher among patients with CSSs than among those without CSSs (P = 0.010). The CSI score was higher in patients with CSSs than in patients without CSSs (P < 0.001). There were no significant differences in other factors between the two groups.
Table 1 Central sensitivity syndrome prevalence in patients with hip osteoarthritis (N = 175).
Table 2 Demographic and clinical factors.
Correlations between the pre-operative central sensitization inventory score and post-operative clinical outcomes in patients with and without central sensitivity syndromes
Table 3 indicates the correlations between the pre-operative CSI score and post-operative JHEQ and VAS pain scores in patients with and without CSSs. The CSI score correlated negatively with the pain, function, mental, and total scores on JHEQ in patients without CSSs (pain, ρ = − 0.291, P < 0.001; function, ρ = − 0.209, P = 0.016; mental, ρ = − 0.334, P < 0.001; total, ρ = − 0.305, P < 0.001). In contrast, there were no significant correlations between the CSI score and all clinical outcomes in patients with CSSs.
Table 3 Correlations between the pre-operative central sensitization inventory score and post-operative clinical outcomes in patients with and without central sensitivity syndromes.
Changes in visual analog scale pain score before and after total hip arthroplasty in patients with and without central sensitivity syndromes
Figure 2 shows the VAS pain scores at 1 month pre-operatively and at 3 and 6 months post-operatively in patients with and without CSSs. At baseline (1 month pre-operatively), VAS pain scores did not significantly differ between the two groups (P = 0.456, Cohen’s d = 0.100). However, VAS pain scores were significantly higher at 3 and 6 months post-operatively in patients with CSSs than in those without CSSs (3 months, P < 0.001, Cohen’s d = 0.788; 6 months, P < 0.001, Cohen’s d = 0.556).
Figure 2
VAS pain scores at 1 month before, and 3 and 6 months after total hip arthroplasty in patients with and without CSSs. ‡P < 0.001. VAS visual analog scale, CSS central sensitivity syndrome, Pre 1 month before surgery, 3m 3 months after surgery, 6m 6 months after surgery.
Differences in Japanese Orthopedic Association Hip Disease Evaluation Questionnaire scores after total hip arthroplasty in patients with and without central sensitivity syndromes
Figure 3 indicates differences in JHEQ scores at 6 months after THA between the two groups. VAS satisfaction on JHEQ was lower in patients with CSSs than in those without CSSs (P < 0.001, Cohen’s d = 0.538). Pain, mental, and total scores on JHEQ were also lower in patients with CSSs than in those without CSSs (pain, P = 0.011, Cohen’s d = 0.400; mental, P = 0.032, Cohen’s d = 0.343; total, P = 0.026, Cohen’s d = 0.393). The functional score did not significantly differ between the two groups (P = 0.174, Cohen’s d = 0.271).
Figure 3
JHEQ scores at 6 months after total hip arthroplasty in patients with and without CSSs. (A) VAS satisfaction on JHEQ. (B) Pain, function, mental, and total scores on JHEQ. *P < 0.05 and ‡P < 0.001. VAS visual analog scale, CSS central sensitivity syndrome, JHEQ Japanese Orthopedic Association Hip-Disease Evaluation Questionnaire.
Differences in Japanese Orthopedic Association Hip Disease Evaluation Questionnaire scores after total hip arthroplast according to the number of central sensitivity syndromes
Table 4 shows the influence of the number of CSSs diagnoses (one or ≥ 2) on JHEQ scores after THA in patients with HOA. Both one and ≥ 2 CSS diagnoses impacted VAS satisfaction on JHEQ (one CSS, β = − 0.181, P = 0.019; ≥ 2 CSSs, β = − 0.175, P = 0.023). Furthermore, the presence of ≥ 2 CSSs was the only factor that significantly impacted the pain score on JHEQ (one CSS, β = − 0.093, P = 0.233; ≥ 2 CSSs, β = − 0.175, P = 0.027). Borderline significance (0.05 < P < 0.18) was found between one CSS and mental score, both one and ≥ 2 CSS diagnoses and total scores (mental score, one CSS, β = − 0.110, P = 0.163, ≥ 2 CSSs, β = − 0.073, P = 0.356; total score, one CSS, β = − 0.105, P = 0.177, ≥ 2 CSSs, β = − 0.122, P = 0.142).
Table 4 Impact of the number of central sensitivity syndrome diagnoses on post-operative Japanese Orthopaedic Association Hip-Disease Evaluation Questionnaire scores in patients with hip osteoarthritis: multiple regression analyses (N = 173).
Hi, I am Anna O’Keefe. I have always prided myself for being tough and resilient. But life has just fallen apart due to a hip fracture when a wrong step sent me landing hard on a brick walkway. After a 5 week stay in the hospital and Rehab I am gladly home to Rehab 2 times a week. I am healing slowly but making progress.
But life goes on: rent needs to be paid, monthly expenses addressed. Although it’s been very tough I have managed to just stay afloat with a withdrawal from my retirement fund and my savings account.
But now I am facing very hefty car repairs and I have exhausted all my available funds.
I am asking for help to get these repairs done.
Having my car functioning safely would be a massive relief. I can’t drive currently but will in the next month. Meanwhile I need a reliable car for friends to use to me transport to and from doctor visits, pharmacy and grocery store. When I am released to drive soon I’ll be doing out patient rehab.
Despite what the name might suggest, runner’s lunge isn’t just for runners. It is an energizing pose that stretches, lengthens, and strengthens the hips, hamstrings, quadriceps, and back (via Tummee). What’s more, it’s a great exercise for toning the lower body, aligning the spine, and improving overall balance and posture.
Amongst the many benefits of this stretch, it warms up the body for deeper hip-openers (via Yoga15). From a downward facing dog position, step your right foot between your hands. Adjust yourself if needed, so that your right knee is in line with your right ankle (not in front of it). Also, make sure that your toes are facing forward. Widen your stance so that your feet should are hip distance apart. Then, press through your back heel to lengthen your back leg. Hold this pose for 3-5 deep breaths on each side, then repeat it on the other side.
Total hip replacement is one of the most common non-emergency surgeries. The number of yearly hip replacements performed in the United States is expected to rise to 635,000 by the year 2030 due to the aging population.
Hip replacements are commonly used to treat conditions like arthritis and hip fractures that cause pain and stiffness. The risk of serious complications following a hip replacement is generally low, but all surgeries come with some risk.
Heart attack and other serious cardiovascular complications are possible complications of joint replacement surgeries. The risk of having a heart attack is highest in people with a history of cardiovascular disease and becomes higher with advancing age.
Read on to learn more about the link between hip replacement surgery and heart attacks, including how common heart attacks are after hip surgery, risk factors, and things you can do to prevent them.
A total hip replacement is one of the most successful orthopedic surgeries, with more than a 95 percent survival rate 10 years after the procedure. The majority of hip replacements are performed on people between the ages of 60 to 80.
The single largest cause of death is major adverse cardiac events (MACE), which mostly includes heart attacks. Improvements in surgical techniques and preoperative screening have led to a significant decline in postsurgery death.
The reported 30-day incidence of heart attack ranges from 0.3 to 0.9 percent after total knee or hip replacement.
Why does hip replacement surgery increase the risk of a heart attack?
It’s not exactly clear why your risk of having a heart attack increases after major surgery, but various factors are likely at play.
Some events during surgery may increase stress on your heart. These include:
Inflammation caused during the repair process can increase your blood’s chances of clotting, which can increase your risk of heart problems. Increased heart rate and elevation in blood pressure can put stress on your coronary artery.
With orthopedic surgery, there’s also a risk of developing a fat embolism or cement embolism. That’s when fat or cement from the joint replacement gets released into the bloodstream, causing a blockage or clot. This can cause serious problems with your heart and lungs.
Changes in medications before the surgery, like discontinuing low dose aspirin, may contribute as well.
How common are heart attacks after surgery?
About 3 percent of people undergoing major surgery experience a heart attack during the procedure. Complications become more common with age and in people with a previous history of cardiovascular disease or other risk factors for heart disease.
One in 5 people over 65 or over 45 with a history of cardiovascular disease develop one or more MACE within a year of non-cardiac surgery.
How long is the risk elevated?
Your risk of developing a heart attack remains elevated in the period directly after your surgery, especially in the first week.
In a large 2016 study, researchers found the risk of heart attack became insignificant 1 month after total hip replacement.
Other studies have found that the risk of heart attack remains slightly elevated in the 4 to 6 weeks after hip replacement surgery.
While your risk of a heart attack may decrease after a few weeks, you should still be aware of some other risks. Decreased mobility after hip surgery increases your risk of a blood clot and deep vein thrombosis. This risk will likely persist until you’re active again.
Risk after hip replacement compared to other joint replacements
In a 2021 study, researchers investigated the rates of heart attack among 322,585 people who received spinal fusion or joint replacements. The researchers found that the risk of heart attack was generally higher in people receiving spinal fusion and lower in people receiving knee or hip replacements.
There’s still a limited amount of evidence about how to reduce your chances of a heart attack before surgery. It’s critical to communicate with your doctor ahead of time to evaluate your risk of complications and develop a plan to minimize your chances of developing them.
In evaluating your risk prior to surgery, your doctor will consider several factors, including:
age
overall health and underlying conditions
cardiovascular health
respiratory health
blood pressure
complete blood count
You may undergo several tests as part of the assessment, including:
physical exam
echocardiogram
electrocardiogram
chest X-ray
blood and urine tests
Your doctor may recommend taking medications like statins or beta-blockers leading into your surgery. They may also tell you to reduce or quit smoking and drinking.
Online tools are available to help you assess your risk, but you should always consult with your doctor.
Doctors don’t usually recommend a hip replacement unless your hip is worn to the point it doesn’t respond to physical therapy or steroid injections. It’s almost always an elective surgery. That means it’s not mandatory but performed to improve function and reduce pain.
A promising but developing alternative to a hip replacement for treating osteoarthritis is stem cell injections. These injections contain stem cells that can become cartilage, muscle, or bone. It’s thought that they could help regenerate lost cartilage in your hip.
One small 2018 study found promising results among five people with osteoarthritis. The people in the study experienced an average improvement of 72.4 percent in resting and active pain.
Some conditions that can cause hip pain, like autoimmune arthritis and osteoporosis, are associated with an increased risk of developing a heart attack. But research is yet to show that the conditions are responsible for the higher risk.
Research has found a link between cardiovascular disease and inflammatory forms of arthritis like rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. These conditions cause inflammation throughout your body that may be associated with an increased risk of developing a heart attack.
A 2016 review of studies found that heart disease was 24 percent more common in people with osteoarthritis than in people in the general population.
Studies that look at the prevalence of diseases in large populations have found an observational link between osteoporosis and cardiovascular disease, partly because of shared risk factors like aging.
Researchers have found that the risk of heart attack increases after having a hip replacement. The risk seems to be highest in the month, and particularly in the week, following surgery.
Heart attacks and other surgical complications that affect the heart become more common with advanced age. They’re also more common in people with a history of cardiovascular disease.
It’s important to talk with your doctor before your surgery to evaluate your risk of complications and develop a plan to minimize your risk.
The American College of Rheumatology (ACR)/American Association of Hip and Knee Surgeons (AAHKS) has published guidance regarding perioperative management of antirheumatic medication in patients with rheumatic diseases undergoing elective total hip or total knee arthroplasty.
The American College of Rheumatology (ACR)/American Association of Hip and Knee Surgeons (AAHKS) has published guidance regarding the management of antirheumatic medication in patients with rheumatic diseases undergoing elective total hip or total knee arthroplasty, with emphasis placed on perioperative use of disease-modifying antirheumatic drugs (DMARDs) and glucocorticoids (GCs). The last guideline update was published in 2017.
“Advances in antirheumatic therapy have led to remarkable improvements in treatment and quality of life for people with rheumatic musculoskeletal diseases (RMDs); however, total hip arthroplasty (THA) and total knee arthroplasty (TKA) remain a mainstay of treatment among RMD patients with advanced symptomatic joint damage, most frequently those with inflammatory arthritis (IA), including spondylarthritis (SpA), rheumatoid arthritis (RA), or psoriatic arthritis (PsA), and those with systemic lupus erythematosus (SLE),” investigators stated.
Top Insights:
Patients with RA, PsA, SLE, juvenile idiopathic arthritis (JIA), and ankylosing spondyloarthritis (AS) who are undergoing elective THA or TKA: continuing the usual DMARDs through surgery is conditionally recommended for methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, and/or apremilast.
Patients with RA, PsA, JIA, and AS who are undergoing elective THA or TKA: withholding all biologics prior to surgery and planning surgery after the next dose is conditionally recommended.
Patients with RA, PsA, JIA, and AS who are undergoing THA or TKA: withholding tofacitinib, upadacitinib, and baricitinib for 3 or more days prior to surgery is conditionally recommended.
Patients with SLE who are interested in THA or TKA: continuing the usual dose of mycophenolate mofetil, cyclosporine, mizoribine, azathioprine, mycophenolic acid, or tacrolimus, anifrolumab, and voclosporin is conditionally recommended.
Patients with severe SLE undergoing THA or TKA: planning surgery in the last month of the dosing cycle of rituximab and continuing belimumab treatment is conditionally recommended.
Patients with SLE (not severe) undergoing THA or TKA: withholding the current dose of mizoribine, cyclosporine, azathioprine, mycophenolic acid, mycophenolate mofetil, or tacrolimus 1 week before surgery is conditionally recommended.
Patients with SLE (not severe) undergoing THA or TKA: withholding the usual dose of rituximab and belimumab prior to surgery is conditionally recommended.
Patients with severe SLE undergoing THA or TKA: continuing belimumab and planning surgery in the last month of the dosing cycle of rituximab is conditionally recommended.
Patients with RA, PsA, AS, and SLE who had antirheumatic therapy withheld prior to undergoing THA or TKA: therapy should be restarted once wound begins to heal, there is no significant swelling, erythema, or drainage, sutures and/or staples are out, and there is no nonsurgical site infection. This occurs roughly 2 weeks after surgery and is conditionally recommended.
Patients with RA, AS, PsA, and SLE undergoing THA or TKA receiving GCs: continuing current dose of GCs instead of administering supraphysiologic doses of GCs on the day of surgery is conditionally recommended.
According to data from China’s seventh census in 2020, the 60-year-old population has reached 264 million, accounting for 18.7% of the total population; of which 190 million are 65-year-old, accounting for 13.5% of the total population, and have begun to enter the “aging society”. Concomitantly, the periarticular fragility fracture of the hip, a common serious injury, has significantly increased in incidence.1 Hip fractures are recognized as a major threat to older adults, with nearly one-third of patients dying within a year of a hip fracture, and about 50% of survivors unable to return to their pre-fracture functional status.1,2 Patients with hip fractures experience a variety of complications, including frailty.3 And frailty is a predisposing factor for falls and other adverse events, including organ decline, emergency hospitalization, nursing home admission, and death.4 Moreover, frail patients who are already in poor health will become even frailer due to pain, mobility problems and inability to take care of themselves.5 This creates a bad vicious circle.
Regaining mobility after surgery is a top priority in the treatment of hip fractures in elderly patients. However, the choice of anesthesia for elderly hip fracture surgery remains controversial.6 Previous studies have shown that spinal anesthesia does not provide better outcomes after surgery for elderly patients with hip fractures.7,8 Whereas, there are also many studies support spinal anesthesia as the advantages of shortened hospital stay, higher patient satisfaction, shorter anesthesia recovery time, and reduced postoperative opioid consumption.9–11 In addition, spinal anesthesia has the advantages of fast onset, complete block, and no impact on respiratory function,12 which can be widely used in elderly hip fracture surgery. In fact, with the development of ultrasound-guided intraspinal puncture technology, the success rate of intraspinal puncture including spinal anesthesia has significantly increased,13 which may further improve the satisfaction of spinal anesthesia.
At present, the medication and dosage of spinal anesthesia for elderly patients are basically determined by anesthesiologists based on experience, and the dosage of the medication directly affects the patient’s anesthesia effect, hemodynamics, and further affects the prognosis. In this study, 50% and 95% effective doses of ropivacaine in spinal anesthesia (ED50 and ED95) in elderly patients with hip fracture surgery were determined by a modified sequential design. At the same time, the prediction formula of the individual optimal dose is provided to guide the dose selection of ropivacaine in elderly patients with hip surgery and spinal anesthesia in clinical work.
Materials and Methods
Study Design
This is a prospective, modified up-down sequential allocation study, which was conducted in the Department of Anesthesiology of the First Affiliated Hospital of the University of Science and Technology of China from June 2021 to March 2022, and passed the ethics review of the hospital ethics committee (2021KY113), and completed the registration in the China Clinical Trial Registration Center (ChiCTR2100046982). All study participants read and signed informed consent forms. This trial was conducted in accordance with the Declaration of Helsinki.
Eligibility Criteria
The inclusion criteria included (1) ASA classification II–IV; (2) Age ≥ 65 years old; (3) Elective hip fracture surgery (included femoral neck, femoral head, intertrochanteric or subtrochanteric fractures); (4) Sign the informed consent. Exclusion criteria included (1) Administered sedative and analgesic drugs within 3 hours before surgery; (2) Severe dementia; (3) Have uncontrolled neurological or psychiatric diseases; (4) Severe multiple injuries; (5) Contraindications to spinal anesthesia; (6) Participated in other drug trials within three months.
Anesthesia Procedures
Patients fasted for 8 hours before surgery. After entering the room, a “Venturi” mask with an oxygen flow of 2 L/min was used to inhale oxygen, open the venous access, connect the monitor, and continuously monitor the electrocardiogram (ECG), invasive blood pressure (IBP), pulse oxygen saturation (SpO2) and heart rate (HR). The anesthesia method is combined spinal-epidural anesthesia, the puncture is performed after ultrasound-guided positioning,14 the puncture point is L2-3, 2% lidocaine is selected as the local infiltration anesthesia, and 0.5% ropivacaine diluted with 10% glucose solution was used for spinal anesthesia. The patient is placed in a lateral recumbent position (the affected side is down), and spinal anesthesia is performed first. After the cerebrospinal fluid is confirmed to be smooth, 0.5% ropivacaine is given in about 30 seconds. Then an epidural catheter of 3–5 cm is indwelled in the epidural space. After ropivacaine injection, the lateral decubitus position was maintained for 15min to achieve unilateral block.15 Intraoperatively, additional 1% lidocaine should be added to the epidural space as needed, at the discretion of the anesthesiologist. The epidural catheter was removed after surgery.
Study Interventions
The dose of ropivacaine received by each patient in stage I was determined by a sequential method. Specifically, the initial dose was set at 7.5 mg. When the anesthesia effect of the previous patient was satisfactory, the dose of the next patient was reduced by 0.5 mg; when the anesthesia effect of the previous patient was unsatisfactory, the dose of the next patient was increased by 0.5 mg. In addition, considering the clear effect of height on the dose of spinal anesthesia, the dose should be further corrected by reference to height: for every 10cm increase or decrease in height, the dose should be increased or decreased by 0.5mg.
Definition of Satisfactory Anesthesia: (1) Anesthesia plane (assessed by acupuncture): higher than T10, lower than T6; (2) Pain-free operation within the first hour of surgery.
After the establishment of the optimal dose formula, the validation cohort was included in stage II. Spinal anesthesia was performed using the ropivacaine dose provided by the formula to evaluate the effectiveness of the formula to guide clinical ropivacaine dose selection and the success rate of meeting surgical needs.
Sample Size Calculation
The logistic regression model of this study plans to screen independent variables such as age, gender, height, weight, ASA classification, hemoglobin, white blood cells, red blood cells, and C-reactive protein. The calculation is based on the Events Per Variable principle,16 that is, the sample size is the independent Variable expected to be included multiplied by 10. Furthermore, considering the 20% dropout rate, 114 cases were finally included in the stage I of this study. In stage II, another 30 cases were included to verify the formula. A total of 144 patients.
Statistical Analysis
For numeric variables, the Shapiro-Wilk test was used to verify normality. Normally distributed variables are expressed as the mean (standard deviation), and abnormally distributed variables are expressed using the median (interquartile range). Categorical variables are expressed as numbers (percentages). Independent two-sample t-tests were used to compare normally distributed variables. Abnormally distributed variables were compared using the Mann-Whitney U test. Categorical variables were analyzed using the χ2 test or Fisher’s exact test. Probit regression was used to calculate ED50, ED95 and their 95% confidence interval (CI). Logistic regression was used to screen variables, and odds ratio (OR) was used to describe the variables included in univariate and multivariate regression models. Meanwhile, nomogram is established, and C-index evaluates its predictive ability. For patients who meet satisfactory anesthesia, a multiple linear regression model is used to establish a dose prediction equation. Data were analyzed using SPSS (version 24.0; SPSS Inc., IBM, Chicago, IL, USA). All statistical tests were two-tailed, and a P-value less than 0.05 was defined as statistically significant.
Results
Overall, a total of 180 patients were screened in this study between June 2021 and April 2022. Among them, in stage I, 15 patients refused to participate, 14 patients did not meet the criteria for admission, and 2 patients were unsuccessful in spinal anesthesia; In stage II, 1 patient refused to participate, and 4 patients did not meet the criteria for admission. A total of 144 patients completed the study, 114 in stage I and 30 in stage II. The complete selection flow chart of subjects in this study is shown in Figure 1. Baseline characteristics such as demographics and surgical information are shown in Table 1.
Table 1 Baseline Characteristics
Figure 1 Flow chart of the study.
ED50 (CI) and ED95 (CI)
According to the calculation results of Probit regression, the ED50 and ED95 of ropivacaine for spinal anesthesia of elderly hip fracture were 7.036 mg (95%CI 6.549–7.585 mg) and 8.709 mg (95%CI 7.902–14.275 mg), respectively. Goodness-of-fit test of the model P=0.108 > 0.05. The specific dose and the corresponding number of cases are shown in Table 2.
Table 2 Dose and Corresponding Number of Cases
Variable Filtering and Nomogram
Nine independent variables were included in this study and entered into logistic regression, including age, gender, height, weight, ASA classification, hemoglobin, white blood cells, red blood cells, and C-reactive protein. Group comparisons are made according to whether satisfactory anesthesia is achieved. Comprehensive consideration of univariate analysis results and clinical practice, and finally screen out age, gender, height, and weight into the model. Crude and adjusted OR are shown in Table 3. It should be explained that the OR value failed to reflect the correlation between height and anesthesia effect because the sequential plan was modified by using height in this study.
Table 3 Multivariate Logistic Regression Model
Additionally to that, we visualized the logistic regression model using the nomogram constructed by the factors described above (Figure 2). Using C-index to evaluate the discrimination of the nomogram, C-index=0.847 (95%CI 0.774–0.92), suggesting good prediction accuracy. The nomogram model was internally verified by Bootstrap repeated 1000 times sampling method, and the calibration curve of the prediction model was obtained (Figure 3), which showed that the prediction model was in good consistency with the actual observed results.
Figure 2 Nomogram to predict probability of satisfactory anesthesia.
Figure 3 Calibration curve for nomogram.
Formula for Predicting the Optimal Dose
According to the definition of satisfactory anesthesia in this study, there were 58 patients with appropriate anesthesia plane and satisfactory analgesic effect within the first hour of surgery. Based on this, the multiple linear regression model was used to incorporate age, gender, height and weight into the model as independent variables, and the following formula can be calculated: Dose(mg) = -1.39 + age(year)*0.011 – gender(male = 1; female = 0)*0.249 + height(cm)*0.047 + weight(kg)*0.005
This calculation equation has statistical significance, F=5.691, P=0.001<0.05, indicating that there is a linear correlation between the dependent variable and the independent variable. Correlation coefficient R=0.548, determination coefficient R2=0.3.
Verification of Efficacy and Safety of the Formula
The stage II of this study included 30 patients, and the same anesthesia protocol was implemented as the stage I. The ropivacaine dose was provided by the prediction equation established in stage I. Finally, the anesthesia plane of 1 patient was below T10, 1 patient felt pain during skin incision, and the other 1 patient were satisfied with analgesia at the beginning of the operation, but the duration was less than 1 hour. The anesthesia plane of the 27 patients was suitable and could provide a completely satisfactory anesthesia effect within the first hour of surgery, indicating that the formula had an effective rate of 90%. Namely, this predictive formula can guide clinical ropivacaine dose selection to a considerable extent.
Perioperative Events
The perioperative-related adverse events in this study were mainly hemodynamic changes, including hypertension and hypotension after spinal anesthesia. In stage I, 20 patients had hypotension and 11 patients had hypertension. The cases of hypotension and hypertension in stage II were both 3. It should be noted that there was no significant and uncorrectable hypotension during the trial. The occurrence of hypertension may be related to the nervousness of patients during the operation. The number of patients with inappropriate anesthesia plane or insufficient analgesia within the first hour of surgery according to the definition of satisfactory anesthesia is shown in Table 4.
Table 4 Perioperative Events
In stage I, after surgery, 99 patients (86.84%) were directly transferred to the ward, 9 (7.89%) were transferred to PACU, and 6 (5.26%) were transferred to ICU. In the stage II, after surgery, 28 patients (93.33%) were directly transferred to the ward, 2 (6.67%) were transferred to PACU, and none were transferred to the ICU.
Discussion
In this prospective, modified up-down sequential allocation study, we first calculated the ED50 and ED95 of ropivacaine for spinal anesthesia in the elderly with hip fractures, with specific values of 7.036 mg and 8.709 mg, respectively. After that, by screening the factors affecting the anesthetic effect, a more intuitive nomogram for predicting satisfactory anesthesia was established. The calculation formula for predicting the optimal dose of ropivacaine is then provided directly through the multiple linear regression model, and the factors included in the regression model included age, gender, height, and weight. After that, in stage II, the ropivacaine dose provided by the formula was used for spinal anesthesia, and the success rate was 90%. To our knowledge, this study is the first to provide a formula for calculating the optimal dose of ropivacaine for elderly hip fracture surgery.
Mei et al showed that the ED50 and ED95 of hyperbaric ropivacaine for cesarean section were 11mg and 15mg,17 and the sequential study of Lv et al showed that the ED50 of hyperbaric ropivacaine for cesarean section was 8.29mg.18 Practically, due to high abdominal pressure and distended intraspinal veins, the drug dose required for spinal anesthesia for puerperae is lower than that of non-puerperae women. However, the dose in the above study was still significantly higher than the ED50 and ED95 of 7.036 mg and 8.709 mg in this study. We believe that the main reason for the difference is that, in this study, after ropivacaine was injected into the subarachnoid space, the lateral decubitus position was maintained for 15 minutes, which enabled the realization of Unilateral spinal anesthesia. Secondly, the puncture point of L2-3 can also reduce the dosage of anesthetic drugs. Advanced age may be another reason.
There are many factors influencing the effect of spinal anesthesia. Age, height, weight, body position, drug specific gravity, liquid volume, concentration, injection speed, puncture point, patient position, abdominal circumference, and even lumbosacral cerebrospinal fluid volume can all affect the anesthesia block plane.19–24 In this trial, we controlled the controllable factors as much as possible, and the patient’s body position, puncture point, drug specific gravity, concentration, and injection speed were all kept consistent. On this basis, statistical analysis first found that age was a statistically significant influencing factor. Moreover, height, as part of the modified sequential protocol, also indisputably influenced the trial results. Furthermore, considering that elderly patients have large differences in body weight, and gender may affect patients’ perception of pain. Finally, four factors of age, gender, height, and weight are included in the statistical model. Then, we used these four factors to build a nomogram in order to more intuitively discover the impact of the inclusion factors on the probability of satisfactory anesthesia.
The dose of spinal anesthesia drugs significantly affect the anesthesia effect, including the analgesia plane, hemodynamics, and even long-term prognosis.25 The physiological homeostasis of the elderly is significantly more likely to be affected due to their weak vascular elasticity and poor nutritional status. At present, there is no unified plan for dose selection for elderly hip fracture surgery. Our study provides a formula for the dose selection of ropivacaine for spinal anesthesia, and the effective rate is 90%, which has high practical value. It is worth mentioning that the definition of satisfactory anesthesia in this study is that there is no pain within the first hour of the operation. Although the duration is not long, it can fully ensure that the dose is not excessive and the hemodynamics is stable. Furthermore, considering that surgically destructive stimulation, including skin incision and reamed intramedullary, occurs mainly within the first hour, the dose provided by the formula can be considered the lowest and optimal option.
Previous literature has suggested that appropriate spinal anesthesia has better perioperative hemodynamic stability than general anesthesia, and the need for intraoperative vasopressors is also significantly reduced.26 In elderly patients, the incidence of blood pressure drop after spinal anesthesia can be as high as 75%.27 In contrast, in this study, the incidence of hypotension after spinal anesthesia was only 20% in stage I and 10% in stage II. The main reason for this advantage is that unilateral anesthesia was well implemented in this trial, and only unilateral sympathetic nerves were blocked as much as possible. Moreover, the definition of satisfactory anesthesia in this study is relatively loose, and it is not mandatory that a single dose can meet the needs of the entire operation, resulting in a significant reduction in drug dosage. In addition to hemodynamics, the postoperative destination is also worthy of attention. In this study, the proportion of patients directly transferred to the general ward after surgery was as high as 86.84% and 93.33% respectively in the two trial stages, which may bring significant improvement in patient satisfaction and also help alleviate the shortage of anesthesia medical resources in China. It is worth noting that in stage II, when dose selection was guided by the calculation formula, the number of patients admitted to the ICU was 0, while the literature reported that the ICU transfer rate was about 7% in the elderly after surgery for hip fracture under general anesthesia.28 Given that the median age of patients in this study was as high as 80 years, the prognostic advantage of reducing the rate of ICU admission may have been greater than expected.
In addition to the above, there are some peculiarities in this study in terms of the trial protocol. First, the puncture site for spinal anesthesia was L2-3, considering that previous studies have provided some dosage options for L3-4.25,29 And due to factors such as hyperosteogenesis and ligament calcification in elderly patients,30 there are always some cases of failed puncture in the L3-4 space. At that time, L2-3 is a safe additional choice. Moreover, ultrasound-guided positioning can ensure the accuracy of puncture point. Second, we chose hyperbaric liquid in this trial, based on the fact that hyperbaric liquid can achieve anesthesia block effect more quickly than hypobaric and isobaric,31,32 and is more popular among surgeons.
There are also some limitations worth discussing in this study. First, this study did not set up a control group, but only a dose-finding test of ropivacaine in a single group. It is still necessary to compare with other commonly used drugs for spinal anesthesia such as bupivacaine in the future to determine the best choice of drug types. Second, this study paid relatively little attention to the prognosis of patients, mainly because we focused on the evaluation of intraoperative anesthesia effect, and the comparison of prognosis also needed to set up a control group. Last but not least, the calculation of the sample size of this study is based on the minimum sample size of logistic regression, which does not mean that the sample size is sufficient. In particular, the efficacy and safety of the calculation formula need to be confirmed by clinical trials with larger samples, or even randomized controlled trials.
At present, the debate on the pros and cons of different anesthesia options for elderly hip fractures is still ongoing. This study starts with spinal anesthesia, focuses on the dose selection of ropivacaine, and gives a specific calculation formula, which meets the requirements of precise anesthesia. Subsequent research can further compare the different densities of drugs and different types of drugs in spinal anesthesia, and screen the optimal general anesthesia scheme at the same time. Finally, comparing the optimal spinal anesthesia scheme with the optimal general anesthesia scheme is the future direction to explore the choice of anesthesia for elderly hip fracture surgery.
Conclusion
In conclusion, this study explored the optimal dose of ropivacaine for spinal anesthesia in elderly hip surgery. The ED50 and ED95 were 7.036 mg and 8.709 mg respectively. A nomogram for predicting satisfactory anesthesia was established with high accuracy. In addition, this study also provides a dose prediction equation of ropivacaine, which has high efficacy and safety, and can guide anesthesiologists in the choice of dose in clinical practice.
Data Sharing Statement
Six months after the main results are published, the individual participant data of this research report can be accessed with the permission of the corresponding authors. The study protocol, statistical analysis plan, and clinical study report will also be available.
Acknowledgments
Appreciate for the support from the Orthopedist and nursing teams of the First Affiliated Hospital of USTC.
Author contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Funding
This research was not funded by any source in the public, commercial, or nonprofit sectors.
Disclosure
The authors report no conflicts of interest in this work.
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LISBON, Portugal ― Screening for Staphylococcus aureus, decolonization, and use of teicoplanin for surgical antimicrobial prophylaxis among patients with methicillin-resistant S aureus (MRSA) lowered the number of prosthetic joint infections in elderly patients undergoing surgery for fracture of the femur.
The findings were presented here as a poster at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022, which was one of the few awarded the accolade of “top-rated poster.”
“We actually found that with our intervention, all prosthetic joint infections decreased, not just the Staphylococcus aureus but those due to MRSA, too,” said Natividad Benito, MD, an infectious diseases specialist at Hospital de la Santa Creu i Sant Pau in Barcelona, Spain, in an interview with Medscape Medical News. “We’re pleased with these results because prosthetic joint infections present such a complicated situation for patients and surgeons. This is also a relatively easy intervention to use, and with time, even the PCR [polymerase chain reaction] technology will become cheaper. Now, in our hospital, prosthetic joint infections are rare.”
At the Hospital de la Santa Creu i Sant Pau, around 200 hip hemiarthroplasties are performed per year. Preceding the intervention, the hospital recorded 11 prosthetic joint infections, with up to five infections due to S aureus and up to four due to MRSA.
The intervention was introduced in 2016. After 2 years, there were no cases of prosthetic joint infections due to S aureus; in 2018 there, was one case of prosthetic joint infection due to MRSA. In 2019, there was one case of prosthetic joint infection, but it was due neither to S aureus nor MRSA. In 2020 and 2021, there was one infection each year that was due to MRSA.
Jesús Rodríguez Baño, MD,head of the Infectious Diseases Division, Hospital Universitario Virgen Macarena at the University of Seville, Spain, who was not involved in the study, explained that for patients with hip fracture, “the time frame in which colonization can be studied is too short using traditional methods. Prosthetic joint infections in this population have a devastating effect, with not negligible mortality and very important morbidity and healthcare costs.”
Referring to the significant reduction in the rate of S aureus prosthetic joint infections in the postintervention period, Rodríguez Baño told Medscape Medical News, “The results are sound, and the important reduction in infection risk invites for the development of a multicenter, randomized trial to confirm these interesting results.
“The authors are commended for measuring the impact of applying a well-justified preventive protocol,” RodríguezBaño added. However, the study has some limitations: “It was performed in one center, it was not randomized, and control for potential confounders is needed.”
Decolonization in an Emergency Femur Fracture
This study addressed a particular need in residents of Spain’s long-term care facilities. In 2016, the prevalence of MRSA was high.
Roughly one third of the general population carry S aureus in their nose. In care homes, the rate of MRSA is higher than in the general population, at around 30% of those with S aureus. In Spain, recommendations for patients undergoing elective total joint arthroplasty advise S aureus decolonization — which can take 5 days — to prevent surgical site infections.
“The problem with the elderly population is not only have they a higher incidence of MRSA but that the surgical prophylaxis is inadequate for MRSA,” Benito pointed out.
Many patients in long-term care facilities are elderly and frail and are at greater risk of fracture. Unlike elective hip surgery, in which patients are asked to undergo decolonization over the 5 days prior to their operation, with emergent femur fractures, there is insufficient time for such preparation. “These patients with femur fractures need surgery as soon as possible,” said Benito.
No studies have been conducted to determine the best way to minimize infection risk from S aureus and MRSA for patients undergoing emergency hip hemiarthroplasty surgery to treat femoral fractures.
In the current study, Benito and her co-authors assessed whether a bundle of measures — including rapid detection of S aureus nasal carriage by PCR upon arrival in the emergency setting, followed by decolonization of carriers using a topical treatment in the nose and a prescription of surgical antimicrobial prophylaxis (adapted antibiotic prophylaxis for MRSA) — reduces the incidence of prosthetic joint infections after surgery.
The quasi-experimental single-center study included patients admitted to the emergency department at Hospital de la Santa Creu i Sant Pau. The PCR was rapid, with a turnaround of just 1.5 hours. Decolonization of S aureus carriers was carried out using nasal mupirocin and chlorhexidine gluconate bathing, which was started immediately. It was used for a total of 5 days and was usually continued throughout and after surgery.
Patients carrying MRSA received teicoplanin as optimal surgical antimicrobial prophylaxis instead of cefazolin. The intervention did not interfere with the timing of surgery. The study’s principal outcomes were overall incidence of prosthetic joint infections and the incidence of those specifically caused by S aureus and MRSA.
The researchers compared findings regarding these outcomes over 5 consecutive years of the intervention to outcomes during 4 consecutive years prior to the intervention, which started in 2016.
In 2016–2020, from 22% to 31% of the overall number of patients requiring hip hemiarthroplasty were referred from long-term care facilities. From 25% to 29% of these patients tested positive for S aureus on PCR, and of these, 33% to 64% had MRSA.
There were 772 surgical procedures from 2012–2015 and 786 from 2017–2020.
Prior to the intervention, over the years 2012–2014, S aureus caused 36% to 50% of prosthetic joint infections; 25% to 100% of the S aureus infections were MRSA. This decreased significantly after the intervention.
In 2016–2020, there was an average of 14 prosthetic joint infections (1.5%), compared to 36 (4.7%) in 2012–2015 (P < .001). Similarly, the incidence of prosthetic joint infections due to S aureus dropped to 0.3% from 1.8% (P < .002). The incidence of MRSA prosthetic joint infections was 0.3% for 2016–2020, vs 1.2% for 2012–2015 (P = .012).
The years 2018, 2020, and 2021 each saw one case of infection due to MRSA. They were most likely due to “the intervention not being performed properly in all cases,” said Benito.
A prosthetic joint infection is very serious for the patient. “It means reoperating, because antibiotics are not enough to clear the infection. The biofilm and pus of the infection need to be cleaned out, a new prosthesis is needed, after which more antibiotics are needed for around 2 months, which can be hard to tolerate, and even then, the infection might not be eradicated,” explained Benito. “Many of these people are old and frail, and mortality can be significant. Getting a prosthetic joint infection is catastrophic for these patients.”
32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022: Abstract 02516.
Benitos and Rodríguez-Baño have disclosed no relevant financial relationships.
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