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

Trial Summary

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 data supports the effectiveness of the treatment Neuraxial Anesthesia for surgery?

Research shows that neuraxial anesthesia, which includes spinal and epidural anesthesia, can reduce the risk of complications and death after surgery. It is also popular for helping patients recover faster and move around sooner after surgery. ^{1 2 3 4 5}

Is neuraxial anesthesia generally safe for humans?

Neuraxial anesthesia, which includes spinal and epidural anesthesia, is generally considered safe, but there are rare risks of serious complications like cardiac arrest, neurological damage, and infections. Most complications are uncommon, and the practice requires careful management to minimize risks. ^{6 7 8 9 10}

How is neuraxial anesthesia different from other treatments for surgery?

Neuraxial anesthesia, which includes spinal and epidural anesthesia, is unique because it provides pain relief by blocking nerve signals in specific areas of the body, allowing for increased patient mobility and quicker recovery compared to general anesthesia. It is particularly beneficial for surgeries where targeted pain relief is needed without affecting the entire body. ^{2 3 4 11 12}

What is the purpose of this trial?

The ALOFT Pilot Trial will evaluate three pragmatic elements (recruitment, adherence, and follow-up) of neuraxial versus general anesthesia for lower limb revascularization surgery that are necessary to support a successful, large-scale evaluation. We will concurrently use implementation science methodology to further refine processes for the larger trial. The future full ALOFT trial will be designed to evaluate the comparative effectiveness of two different anesthesia types for improving outcomes.

Research Team

Daniel McIsaac, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Does the evidence support the use of spinal and epidural anesthesia for surgery? [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Postoperative considerations of neuraxial anesthesia. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Recent advances in epidural analgesia. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Does the impact of the type of anesthesia on outcomes differ by patient age and comorbidity burden? [2019]

6. France pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Haematoma, abscess or meningitis after neuraxial anaesthesia in the USA and the Netherlands: A closed claims analysis. [2021]

8. India pubmed.ncbi.nlm.nih.gov

Complications and controversies of regional anaesthesia: a review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

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

10. Poland pubmed.ncbi.nlm.nih.gov

Pneumocephalus Following an Accidental Dural Puncture, Treated Using Hyperbaric Oxygen Therapy. A Case Report. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Epidural and Spinal Anesthesia for Newborn Surgery. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Regional and neuraxial anaesthesia techniques for spinal surgery: a scoping review. [2022]