Neuraxial Anesthesia for Surgery

Overseen By Emily Hladkowicz, PhD (c)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Anticoagulants

Disqualifiers: Multiple sclerosis, Pregnancy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

90 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 individuals undergoing surgery to improve leg blood flow. It compares neuraxial (spinal or epidural) anesthesia with general anesthesia regarding surgical outcomes. Participants will assist researchers in determining the best approach for a larger future study. The trial seeks individuals scheduled for leg artery surgeries who can access a phone for follow-up. As an unphased trial, it offers participants the chance to contribute to foundational research that could influence future surgical practices.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulants, they may need to be held for a certain period based on guidelines.

What prior data suggests that neuraxial anesthesia is safe for lower limb revascularization surgery?

Research has shown that neuraxial anesthesia, which includes spinal and epidural anesthesia, is generally safe and well-tolerated. One study of 1.7 million cases found the risk of a spinal hematoma (a blood clot near the spine) to be very low, about 1 in 200,000 for young women receiving an epidural during childbirth.

Another study found that spinal anesthesia might lower the risk of sudden kidney problems compared to general anesthesia, suggesting it could be a safer choice for some patients. Although rare complications like spinal epidural hematoma can occur, these are uncommon.

Overall, neuraxial anesthesia has a strong safety record, and many patients undergo these procedures without serious issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about neuraxial anesthesia for surgery because it offers a targeted approach to pain management that can minimize the need for systemic medications, like opioids, which are common in general anesthesia. Unlike general anesthesia, which affects the whole body, neuraxial anesthesia acts directly on the nerves around the spinal cord, potentially leading to fewer side effects like nausea and a faster recovery. Additionally, it allows for more personalized care, as anesthesiologists can choose between spinal, epidural, or a combination of both techniques, tailoring the anesthesia to the patient's specific needs. This flexibility and targeted approach could improve patient outcomes and enhance recovery times, making it a promising alternative to the traditional general anesthesia used in surgeries.

What evidence suggests that neuraxial anesthesia is effective for lower limb revascularization surgery?

Research has shown that neuraxial anesthesia, which includes spinal and epidural anesthesia, may offer several advantages over general anesthesia for surgery. In this trial, participants in the intervention arm will receive neuraxial anesthesia, while those in the control group will receive general anesthesia. Studies have found that neuraxial anesthesia can lead to a shorter hospital stay and less pain after surgery. Specifically, for surgeries on the lower limbs, such as revascularization, neuraxial anesthesia has been linked to a lower risk of death within 30 days post-operation. It may also reduce complications like lung and kidney problems, blood clots, and the need for blood transfusions. These findings suggest that neuraxial anesthesia can improve recovery and outcomes for patients undergoing certain surgeries. ^{1 6 7 8 9}

Who Is on the Research Team?

Daniel McIsaac, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

The ALOFT Pilot Trial is for adults over 18 who are scheduled for lower limb revascularization surgery, like arterial bypass or angioplasty. Participants need to be able to use a phone for follow-up. It's not specified who can't join the trial.

Inclusion Criteria

I am scheduled for surgery to improve blood flow in my legs.

Able to access a telephone for postoperative follow-up

Exclusion Criteria

I have multiple sclerosis or a similar nerve condition.

A doctor has decided I'm not fit for this study's random selection process.

I need surgery due to an injury to an artery caused by trauma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lower limb revascularization surgery with either neuraxial or general anesthesia

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments at 30 days, 90 days, and 1 year

1 year

Multiple visits (in-person and virtual)

Extension

Long-term follow-up to assess health-related quality of life and other outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Neuraxial Anesthesia

Trial Overview This pilot study tests neuraxial anesthesia against general anesthesia in surgeries for Peripheral Arterial Disease. It aims to assess recruitment, adherence, and follow-up processes needed for a larger future trial on anesthesia effectiveness.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Intervention arm participants will be allocated to neuraxial anesthesia. The specific approach (spinal, epidural, or combined spinal and epidural) will be at the discretion of the treating anesthesiologist, as the underlying physiologic mechanisms and impacts are similar for both approaches. Allowing clinician discretion will reflect routine standard of care practice and support generalizability. Specific choice of neuraxial anesthetic medications, doses, and adjuncts will also be at the discretion of the attending anesthesiologist, supporting pragmatism. While existing randomized data do not suggest that the sedation level during neuraxial anesthesia leads to differences in outcomes, providers will be requested to maintain sedation at or below a 3 on the Observer's Assessment of Alertness/Sedation scale (OAAS; mild to moderate sedation consistent to responding to verbal stimuli), the same approach used in a recent large pragmatic trial of anesthesia in hip fracture patients.

Group II: Control Active Control 1 Intervention

Control group participants will be allocated to general anesthesia. Choice of anesthetic medications and doses will be at the discretion of each anesthesiologist as per routine standard of care, again supporting conduct of a pragmatic and generalizable trial. Similarly, choice of airway management strategies and anesthetic depth will also be based on patient and provider preference, as a recent large randomized trial demonstrates that anesthetic depth is not causally linked to risk of morbidity or mortality after surgery. Details of general anesthesia management and medications will be collected for all patients.

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

Approved in European Union as Neuraxial Anaesthesia for:

• Lower limb revascularization surgery
• Pain management

Approved in United States as Neuraxial Anaesthesia for:

• Lower limb revascularization surgery
• Pain management
• Obstetric procedures

Approved in Canada as Neuraxial Anaesthesia for:

• Lower limb revascularization surgery
• Pain management

Approved in Japan as Neuraxial Anaesthesia for:

• Lower limb revascularization surgery
• Pain management

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

The Ottawa Hospital Academic Medical Association

Collaborator

Trials

24

Recruited

3,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+

Published Research Related to This Trial

Neuraxial anesthesia, including spinal and epidural techniques, has evolved from being an alternative to general anesthesia to a preferred method for managing perioperative pain, particularly due to the safe and effective use of opioids for spinal analgesia.

The systematic review highlights that improvements in overall perioperative safety enhance the effectiveness of neuraxial analgesia, although the literature analysis reveals inconsistencies that make it challenging to draw definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the evidence support the use of spinal and epidural anesthesia for surgery? Ballantyne, JC., Kupelnick, B., McPeek, B., et al.[2018]

Spinal and epidural anesthesia are effective methods for managing pain during certain surgical procedures, contributing to increased patient mobility and faster discharge times.

Neuraxial blocks are suitable for surgeries where the desired sensory level can be achieved safely, highlighting their growing popularity in regional anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative considerations of neuraxial anesthesia. Cwik, J.[2012]

Neuraxial anesthesia, including spinal and epidural techniques, is widely used in neonates for surgical procedures and is considered very safe when performed correctly.

The article discusses the various benefits and risks associated with neuraxial anesthesia in neonates, highlighting its effectiveness in providing pain relief during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural and Spinal Anesthesia for Newborn Surgery. Whitaker, EE., Williams, RK.[2020]

General anaesthesia is still the most commonly used method for spinal surgery, but regional anaesthesia techniques, particularly non-neuraxial methods like fascial plane blocks, are gaining popularity for their potential to enhance postoperative pain relief and patient satisfaction.

A review of 78 articles indicates that while regional and neuraxial techniques are being increasingly utilized, there is a need for more standardized outcome measures that focus on patient-centered results rather than just physiological metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional and neuraxial anaesthesia techniques for spinal surgery: a scoping review. Ní Eochagáin, A., Singleton, BN., Moorthy, A., et al.[2022]

A review of 28 closed insurance claims related to local and regional anesthesia mishaps revealed that 15 cases involved cardiac arrests, primarily due to factors like hypovolemia, added sedation, and high spinal blocks, indicating critical management issues during anesthesia.

The study highlighted severe outcomes, with 22 patients experiencing poor results, including 8 deaths and 7 severe neurological injuries, emphasizing the need for improved safety protocols in anesthesia practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complications of local and regional anesthesia. An analysis of closed files of insurance companies]. Morisot, P.[2006]

Serious complications from regional anaesthesia are rare, but the incidence is higher for spinal anaesthesia compared to epidural anaesthesia, highlighting the need for careful consideration of risks.

Existing studies on complications are mostly retrospective and do not establish causality, indicating that while there are known risks, the exact reasons for complications in specific patient groups (like those with infections or on anticoagulants) require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications and controversies of regional anaesthesia: a review. Agarwal, A., Kishore, K.[2021]

Out of 12,606 anaesthesia-related incident reports over two years, 22.5% resulted in little to moderate harm, while 2.1% led to severe harm or death, highlighting significant safety concerns in anaesthesia practices.

Pre-operative assessments and epidural anaesthesia were particularly associated with higher rates of harm, indicating areas where improvements in safety protocols could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety in anaesthesia: a study of 12,606 reported incidents from the UK National Reporting and Learning System. Catchpole, K., Bell, MD., Johnson, S.[2022]

A 78-year-old man experienced a rare complication called pneumocephalus after an accidental dural puncture during epidural anesthesia, leading to severe neurological symptoms.

Early recognition of pneumocephalus and prompt treatment with hyperbaric oxygen therapy resulted in complete resolution of symptoms and significant improvement in CT scan findings, highlighting the importance of quick intervention in such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pneumocephalus Following an Accidental Dural Puncture, Treated Using Hyperbaric Oxygen Therapy. A Case Report. Marino, F., Simões, AF., Simas, Â., et al.[2022]

Neuraxial blockade, including epidural and spinal anesthesia, significantly reduces overall mortality by about one-third in postoperative patients, as shown in a systematic review of 141 trials involving 9559 patients.

This technique also lowers the risk of serious complications such as deep vein thrombosis (44% reduction), pulmonary embolism (55% reduction), and respiratory depression (59% reduction), suggesting it is a safer option compared to general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. Rodgers, A., Walker, N., Schug, S., et al.[2023]

Spinal haematomas after neuraxial anaesthesia were frequently linked to errors in managing antihaemostatic medication and delays in diagnosis or treatment, particularly in patients over 60 years old.

Claims related to spinal abscesses and meningitis were often associated with emergency procedures and unsterile practices, highlighting the importance of maintaining sterility and timely intervention during and after neuraxial procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haematoma, abscess or meningitis after neuraxial anaesthesia in the USA and the Netherlands: A closed claims analysis. Bos, EME., Posner, KL., Domino, KB., et al.[2021]

Neuraxial anesthesia significantly reduces the odds of major complications and the need for intensive care after total hip and knee arthroplasties, based on a study of 795,135 patients across approximately 500 hospitals.

The benefits of neuraxial anesthesia are particularly pronounced in older patients without major cardiopulmonary diseases, suggesting it may be a safer option for this demographic during orthopedic surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the impact of the type of anesthesia on outcomes differ by patient age and comorbidity burden? Memtsoudis, SG., Rasul, R., Suzuki, S., et al.[2019]

Epidural anesthesia is an effective technique that can significantly reduce postoperative complications and mortality, highlighting its importance in anesthetic practice.

Understanding the anatomical and technical factors that influence successful epidural block placement is crucial for maximizing its benefits and minimizing risks, especially in patients on anticoagulants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in epidural analgesia. Bauer, M., George, JE., Seif, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11282476/

Impact of spinal or epidural anaesthesia on perioperative ... Reported patient-centred benefits of neuraxial anaesthesia compared with general anaesthesia include decreased length of hospital stay, postoperative pain, ...

2. bmj.com bmj.com/content/371/bmj.m4104

Association between neuraxial anaesthesia or general ... Use of neuraxial anaesthesia compared with general anaesthesia for lower limb revascularisation surgery was associated with decreased 30 day mortality and ...

3. bjaed.org bjaed.org/article/S2058-5349(23)00154-3/fulltext

Strategies for successful lumbar neuraxial anaesthesia ... These outcomes include lower risks of pulmonary and renal complications, venous thrombosis, blood transfusion and possibly mortality. ... 1.

4. uptodate.com uptodate.com/contents/overview-of-neuraxial-anesthesia/print

Overview of neuraxial anesthesia - UpToDate The advantages and disadvantages of the various neuraxial anesthesia techniques are shown in a table (table 3). Spinal anesthesia is usually ...

5. dmr.amegroups.org dmr.amegroups.org/article/view/8168/html

Neuraxial anaesthesia and its role in enhanced recovery after ... Neuraxial techniques have circulatory, analgesic and respiratory benefits and also reduce the stress response to surgery.

6. bjaed.org bjaed.org/article/S2058-5349(24)00077-5/pdf

Neuraxial anaesthesia in the parturient with pre Table 1 Summary of clinical features, potential risks and possible techniques for neuraxial anaesthesia and analgesia in the parturient with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0007091222004275

Clinical effectiveness and safety of spinal anaesthesia ... Spinal anaesthesia reduced the risk of acute kidney injury compared with GA: RR=0.59 (95% CI, 0.39–0.89). There were no significant differences in the risk of ...

8. asahq.org asahq.org/standards-and-practice-parameters/statement-on-neurologic-complications-of-neuraxial-analgesia-anesthesia-in-obstetrics

Statement on Neurologic Complications of Neuraxial ... In a Swedish study of 1.7 million neuraxial blocks, the reported risk of spinal hematoma was 1:200,000 in young women having obstetric epidural ...

9. uptodate.com uptodate.com/contents/overview-of-neuraxial-anesthesia

Overview of neuraxial anesthesia - UpToDate Spinal epidural hematoma (SEH) can rarely occur after an NA procedure if a vascular structure is punctured with a needle or catheter, and ...