Sedation-Epidural vs Spinal Anesthesia for Hip and Knee Surgery

(RCT SEA vs SA Trial)

Overseen By Serge Marquis, inf

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Maisonneuve-Rosemont Hospital

Must not be taking: Anticoagulants, Corticosteroids

Disqualifiers: Obesity, Psychiatric disease, DVT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of anesthesia for hip and knee surgery: Sedation Epidural Anesthesia and Spinal Anesthesia. Researchers aim to determine if either method reduces early post-surgery issues, such as pain or difficulty moving. This effort is part of a plan to help patients recover faster and potentially return home sooner. Individuals with osteoarthritis who require a hip or knee replacement and are already enrolled in a specific recovery program might be suitable candidates. As an unphased trial, this study allows patients to contribute to research that could enhance recovery protocols and improve surgical outcomes.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on long-term anticoagulation therapy or systemic corticotherapy, you may not be eligible to participate.

What prior data suggests that these anesthesia techniques are safe for hip and knee surgery?

Research has shown that spinal anesthesia is a well-tolerated choice for surgeries like hip and knee replacements. Studies have found it often leads to fewer complications than general anesthesia. For instance, patients receiving spinal anesthesia usually have a lower chance of needing a blood transfusion and may face fewer major medical issues, such as stroke or heart attack, within 30 days after surgery.

Recent research suggests that sedation-epidural anesthesia is also a safe option. It is just as safe as general anesthesia regarding the risk of death or surgical complications. This type of anesthesia effectively controls pain without increasing the risk of serious side effects.

Both spinal and sedation-epidural anesthesia have strong safety records, making them reliable choices for hip and knee surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial comparing sedation-epidural anesthesia (SED-EA) and spinal anesthesia (SA) for hip and knee surgeries. Unlike traditional spinal anesthesia, which involves directly injecting a local anesthetic into the spinal fluid for immediate effect, the SED-EA technique uses an epidural catheter to deliver anesthesia, allowing for more precise dosage control and potentially longer-lasting pain management. Additionally, SED-EA might offer a more tailored approach to anesthesia, with the potential for fewer side effects due to its adjustable dosing. By exploring these two methods, researchers hope to determine which provides better pain control and recovery outcomes for patients undergoing these common surgeries.

What evidence suggests that this trial's anesthesia techniques could be effective for hip and knee surgery?

This trial will compare sedation epidural anesthesia (SED-EA) with spinal anesthesia (SA) for hip and knee surgeries. Studies have shown that both SED-EA and SA can be effective for these procedures. Research suggests that spinal anesthesia may lead to fewer blood transfusions and lower risks of complications like death and confusion. It also appears to save money, with shorter times needed for anesthesia and recovery. In contrast, SED-EA, which affects the spine, is linked to better outcomes during and after surgery compared to general anesthesia, potentially reducing pain and other negative effects post-surgery. Overall, both methods have shown promising results in aiding recovery and reducing complications. ^{4 5 6 7 8}

Who Is on the Research Team?

Mina Morcos, Dr

Principal Investigator

Ciusss de L'Est de l'Île de Montréal

Are You a Good Fit for This Trial?

This trial is for adults needing outpatient hip or knee surgery who can safely receive anesthesia. It's not suitable for those with specific health conditions that could interfere with the study, allergies to anesthetics, or a history of substance abuse affecting pain perception.

Inclusion Criteria

I have someone to help me during my surgery and the first week of recovery.

I am able to understand and agree to the study's procedures and risks.

Patient who is candidate for our ERAS program

Exclusion Criteria

I need special care during surgery due to my chronic health conditions.

I have a condition that affects my nervous system or balance.

I have a bleeding disorder that could make surgery risky.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Preoperative assessments including pain levels and opioid/analgesics consumption

1 day

1 visit (in-person)

Surgery and Immediate Postoperative

Participants undergo THA/TKA surgery with either SA or SED-EA anesthesia. Immediate postoperative monitoring for adverse events and complications.

1 day

Inpatient stay

Postoperative Monitoring

Monitoring of pain, opioid consumption, and complications up to 72 hours after surgery

3 days

Daily assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sedation Epidural Anesthesia
• Spinal Anesthesia

Trial Overview The study compares two types of numbing methods during surgery: spinal anesthesia and sedation-epidural anesthesia. The goal is to see which one leads to fewer complications like pain, low blood pressure, inability to urinate, and muscle weakness after surgery.

How Is the Trial Designed?

Group I: SA Active Control 1 Intervention

SA will be performed in the sitting or lateral position under sterile conditions. Spinal puncture will be performed at L2-L4 level using 50 mg of Clorotekal 1 or 2%. (intermediate-acting amide local anesthesia, commonly used) will be injected (32-34)

Group II: SED-EA Active Control 1 Intervention

EA will be performed in the sitting or lateral position under sterile conditions. Epidural puncture will be performed at the L2-L4 level and an epidural catheter will be inserted into the epidural space. 10 ml of 2% xylocaine without epinephrine will be injected through the catheter and the dose will be titrated (up to 20 mL) to achieve complete sensory block up to T12 dermatoma measured with a level to ice.

Sedation Epidural Anesthesia is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sedation-Epidural Anesthesia for:

• Pain management during hip or knee arthroplasty

Approved in European Union as Sedation-Epidural Anesthesia for:

• Pain management during hip or knee arthroplasty

Approved in Canada as Sedation-Epidural Anesthesia for:

• Pain management during hip or knee arthroplasty

Who Is Running the Clinical Trial?

Maisonneuve-Rosemont Hospital

Lead Sponsor

Trials

102

Recruited

38,300+

Pierre Drolet

Collaborator

Trials

1

Recruited

130+

Mina Wahba Morcos

Collaborator

Trials

1

Recruited

130+

Ariane Clairoux

Collaborator

Trials

1

Recruited

130+

Veronique Brulotte

Collaborator

Trials

1

Recruited

130+

Philippe Richebé

Collaborator

Trials

1

Recruited

130+

Marie-Eve Bélanger

Collaborator

Trials

1

Recruited

130+

Issam Tanoubi

Collaborator

Trials

1

Recruited

130+

Karina Pellei

Collaborator

Trials

1

Recruited

130+

Published Research Related to This Trial

Spinal anaesthesia is an effective method for providing anaesthesia during primary total knee replacement, offering several advantages over opioid-based general anaesthesia.

While pre-medication and sedation can help reduce anxiety for patients awake during the procedure, sedation also has potential drawbacks that need to be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Audio-visual distraction during spinal anaesthesia for orthopaedic surgery. O'Connor, K., Pace, N.[2022]

In a study of 3,081 patients undergoing total hip or knee replacement, those receiving general anesthesia had a significantly higher risk of surgical site infections (SSIs) within 30 days (2.8%) compared to those receiving epidural or spinal anesthesia (1.2%).

Patients under general anesthesia were found to have 2.21 times higher odds of developing SSIs compared to those under epidural or spinal anesthesia, highlighting the importance of anesthesia choice in surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthetic management and surgical site infections in total hip or knee replacement: a population-based study. Chang, CC., Lin, HC., Lin, HW., et al.[2022]

In a study of 40,852 patients undergoing total hip and knee arthroplasty, spinal anaesthesia was found to significantly reduce the risk of cardiac, pulmonary, gastrointestinal, and thromboembolic complications compared to combined spinal and epidural (CSE) anaesthesia.

Spinal anaesthesia also led to a shorter length of hospital stay, indicating it may provide a more favorable postoperative outcome profile compared to CSE, while epidural anaesthesia showed no significant differences in outcomes when compared to CSE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuraxial anaesthesia techniques and postoperative outcomes among joint arthroplasty patients: is spinal anaesthesia the best option? Weinstein, SM., Baaklini, LR., Liu, J., et al.[2019]

A study involving 119 children aged 2 to 16 years showed that balanced spinal epidural anesthesia provides effective intraoperative and early postoperative pain relief during orthopedic surgeries on the lower extremities.

The method involved sequential punctures in the subarachnoid and epidural spaces, and it was found to be more effective than conventional general anesthesia, which was used in a control group of 60 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Balanced spinal-epidural anesthesia in pediatric orthopedics]. Abramov, AD., Lekmanov, AU., Popov, VV., et al.[2007]

In a study of 35,878 Medicare patients who underwent elective total knee replacement, the use of postoperative epidural analgesia did not lead to a decrease in mortality within 30 days after surgery.

The analysis showed no significant difference in major morbidity rates between patients who received epidural analgesia and those who did not, indicating that this pain management technique may not improve short-term outcomes in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of postoperative epidural analgesia with morbidity and mortality following total knee replacement in Medicare patients. Wu, CL., Demeester, JS., Herbert, R., et al.[2010]

In a study of 65 patients undergoing hip arthroplasty, spinal anaesthesia provided a quicker onset of sensory blockade and required less propofol for sedation compared to epidural anaesthesia, making it a more efficient option.

Spinal anaesthesia resulted in better operating conditions with less patient movement and fewer catheterizations needed, indicating its potential advantages in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of spinal and epidural anaesthesia for hip arthroplasty. Davis, S., Erskine, R., James, MF.[2018]

In a study of 45,874 patients undergoing hip fracture surgery, neuraxial anesthesia was associated with lower rates of postoperative complications (11.0%) compared to general anesthesia (12.9%).

After adjusting for various factors, general anesthesia was found to significantly increase the risk of postoperative morbidity (19% higher) and mortality (9% higher) compared to neuraxial anesthesia, suggesting that neuraxial anesthesia may lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General versus Neuraxial Anesthesia on Clinical Outcomes in Patients Receiving Hip Fracture Surgery: An Analysis of the ACS NSQIP Database. Wang, MT., Chang, CC., Liu, CC., et al.[2023]

A case report highlights a rare but serious complication of combined spinal-epidural anesthesia (CSE) in a patient who developed a subdural hematoma after total knee replacement surgery, leading to sudden neurological deterioration.

Despite the successful surgical intervention to relieve the hematoma, the patient experienced a persistent foot drop on the left side, indicating that while CSE is generally safe, there can be significant risks associated with its use, especially in the context of postoperative anticoagulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal subdural hematoma with cauda equina syndrome: A complication of combined spinal epidural anesthesia. Singhal, N., Sethi, P., Jain, JK., et al.[2020]

In a study of 198 patients undergoing total hip arthroplasty, caudal epidural anesthesia (CEA) and spinal-epidural anesthesia (SEA) resulted in fewer postoperative adverse effects compared to general anesthesia (GA).

Patients receiving GA required more pain relief post-surgery and exhibited higher levels of β-amyloid expression and worse cognitive function, as indicated by lower MMSE scores, compared to those in the CEA and SEA groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of 3 Different Anesthesia Techniques Used in Total Hip Arthroplasty. Liang, C., Wei, J., Cai, X., et al.[2019]

A systematic review of 29 studies with 10,488 patients found that neuraxial anaesthesia (spinal or epidural) significantly reduced hospital stay by an average of 0.40 days compared to general anaesthesia for total hip and knee surgeries.

No significant differences were observed in mortality, surgical duration, or major complications between neuraxial and general anaesthesia, indicating that neuraxial anaesthesia is equally effective and safe for these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuraxial vs general anaesthesia for total hip and total knee arthroplasty: a systematic review of comparative-effectiveness research. Johnson, RL., Kopp, SL., Burkle, CM., et al.[2022]

A systematic review of 17 randomized controlled trials involving 1,903 participants found no significant differences in mortality or major complications between neuraxial anesthesia and general anesthesia for orthopedic surgery.

The evidence is currently insufficient to definitively conclude that neuraxial anesthesia is safer or more effective than general anesthesia, although the possibility of clinically important differences cannot be ruled out.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuraxial anesthesia for orthopedic surgery: systematic review and meta-analysis of randomized clinical trials. Barbosa, FT., Castro, AA., Sousa-Rodrigues, CF.[2018]

In a study of 60 patients undergoing knee replacement, combined femoral (3-in-1) and sciatic nerve blocks provided better pain control at 24 hours post-surgery compared to epidural blockade, with significantly lower visual analogue scale (VAS) pain scores.

Both analgesic techniques resulted in low total morphine usage and high patient satisfaction, indicating that combined nerve blocks are a safe and effective alternative to epidural analgesia for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural infusion or combined femoral and sciatic nerve blocks as perioperative analgesia for knee arthroplasty. Davies, AF., Segar, EP., Murdoch, J., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7325684/

Comparative efficacy of Neuraxial and general anesthesia ... This meta-analysis was performed to compare the effect of neuraxial (epidural/spinal) versus general anesthesia on perioperative outcomes in patients undergoing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10481314/

A Review of the Anesthesia Choices and Analgesic Options We reviewed the most up-to-date trends for outpatient TJA and discussed essential factors for a successful outpatient program.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06332443

Study Details | NCT06332443 | Randomized, Controlled ... Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty. Conditions.

4. academic.oup.com academic.oup.com/bja/article/116/2/163/2566106

Neuraxial vs general anaesthesia for total hip and total knee ... There is limited quantitative evidence to suggest that neuraxial anaesthesia is associated with improved perioperative outcomes.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2113514

Spinal Anesthesia or General Anesthesia for Hip Surgery ... Observational studies have suggested that spinal anesthesia may be associated with lower risks of death, delirium, and major medical complications and with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9910245/

Spinal anesthesia is a grossly underutilized gold standard ... Spinal anesthesia is associated with decreased complications after total knee and hip arthroplasty. J Am Acad Orthop Surg. 2020;28:E213–E221 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9642835/

Clinical effectiveness and safety of spinal anaesthesia ... We conducted a systematic review and meta-analysis of contemporary RCTs to determine the clinical effectiveness of spinal vs general anaesthesia (SA vs GA)

8. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224002617

Impact of spinal or epidural anaesthesia on perioperative ... This narrative review summarises recent (2018-2023) evidence about patient-centred outcomes associated with spinal and epidural anaesthesia and analgesia.