Neuraxial Anesthesia for Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ottawa Hospital Research Institute
Must not be taking: Anticoagulants
Disqualifiers: Multiple sclerosis, Pregnancy, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
678910How 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.
2341112Eligibility 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
I am 18 years old or older.
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.
+4 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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: ControlActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ottawa HospitalOttawa, Canada
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Who Is Running the Clinical Trial?
Ottawa Hospital Research InstituteLead Sponsor
The Ottawa Hospital Academic Medical AssociationCollaborator
Canadian Institutes of Health Research (CIHR)Collaborator
University of OttawaCollaborator
References
Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. [2023]To obtain reliable estimates of the effects of neuraxial blockade with epidural or spinal anaesthesia on postoperative morbidity and mortality.
Does the evidence support the use of spinal and epidural anesthesia for surgery? [2018]When spinal and epidural anesthesia were introduced into clinical practice, their primary use was as an alternative to general anesthesia. Later, largely as a result of the realization that opioids could be safely and effectively used to produce selective spinal analgesia, spinal and epidural (neuraxial) analgesia began to be used specifically for the treatment of perioperative pain. We present a systematic review of the literature on neuraxial anesthesia and analgesia, new meta-analyses that illustrate the powerful effect of improvements in perioperative safety in general on the ability of neuraxial techniques to make a difference, and a consideration of why a literature analysis does not provide clear answers.
Postoperative considerations of neuraxial anesthesia. [2012]Spinal and epidural anesthesia and analgesia, and the combination of the two techniques, have been excellent choices for the management of certain surgical procedures and continue to grow in popularity. The demand for increased patient mobility and quicker discharge for both inpatients and outpatients lends itself to the benefits of regional anesthesia. A neuraxial block is indicated for any surgical procedure in which the appropriate sensory level can be accomplished without any adverse outcome. This article outlines the indications and contraindications for these techniques.
Recent advances in epidural analgesia. [2021]Neuraxial anesthesia is a term that denotes all forms of central blocks, involving the spinal, epidural, and caudal spaces. Epidural anesthesia is a versatile technique widely used in anesthetic practice. Its potential to decrease postoperative morbidity and mortality has been demonstrated by numerous studies. To maximize its perioperative benefits while minimizing potential adverse outcomes, the knowledge of factors affecting successful block placement is essential. This paper will provide an overview of the pertinent anatomical, pharmacological, immunological, and technical aspects of epidural anesthesia in both adult and pediatric populations and will discuss the recent advances, the related rare but potentially devastating complications, and the current recommendations for the use of anticoagulants in the setting of neuraxial block placement.
Does the impact of the type of anesthesia on outcomes differ by patient age and comorbidity burden? [2019]Neuraxial anesthesia may provide perioperative outcome benefits versus general anesthesia in orthopedic surgical patients. As subgroup analyses are lacking, we evaluated the influence of the type of anesthesia on outcomes in patient groups of different age and the presence of cardiopulmonary disease.
[Complications of local and regional anesthesia. An analysis of closed files of insurance companies]. [2006]We report a review of closed insurance claims for local and regional anaesthesia mishaps in the main private professional insurance companies. Twenty eight cases with extensive written documentation were discovered, spanning a 6 years interval between 1983 and 1989, involving 21 epidural, 6 spinal and 1 caudal anaesthesias, half with surgical and half obstetrical indication, and excluding all other blocks. Twenty four out of the 28 patients were relatively healthy. ASA I or II, only 4 ASA III. They fitted 4 items of our taxonomy of known complications: 15 cardiac arrests, 10 neurological damages, 1 systemic toxic reaction to local anaesthetic drug and 1 allergic reaction to dextran. The cardiac arrests resulted primarily from the 3 following or contributing factors: hypovolemia (in 3 cases), added sedation (7) and high or total spinal block following reinforcing doses (8). Twenty two had a poor outcome: 8 deaths, 7 severe neurological injuries, a baby was dead and another child had severe neurobehavioral sequellae. The author points out the limitation of this study--a biased sample of all adverse events and inability to derive an incidence. However some of these events reveal patterns of anaesthetic management which lead to poor outcomes.
Haematoma, abscess or meningitis after neuraxial anaesthesia in the USA and the Netherlands: A closed claims analysis. [2021]Severe complications after neuraxial anaesthesia are rare but potentially devastating.
Complications and controversies of regional anaesthesia: a review. [2021]Complications of regional anaesthesia has been recognised from very long time. Fortunately serious complication are rare. Safe, effective practice of neuraxial anaesthesia requires a detailed knowledge of potential complications, their incidence and risk factors associated with their occurrence. The incidence of complication were higher for spinal than for epidural anaesthesia. These complications being rare, so existing studies are mainly retrospective, providing information about incidence and their associations but not necessarily demonstrate causality. There are many areas of controversies regarding the usage of regional anaesthesia i.e. in outpatient surgical procedures, epidural test dose, its safety in infected / febrile / immuno compromised patients, / in patients with neurological disorder and in patients receiving anti-coagulants. Recommendations proposed may be acceptable based on the judgment of the responsible anaesthesiologist. The consensus statements are designed to encourage safe and quality patient care but cannot guarantee a specific outcome.
Safety in anaesthesia: a study of 12,606 reported incidents from the UK National Reporting and Learning System. [2022]The incident reporting database at the National Patient Safety Agency was interrogated on the nature, frequency and severity of incidents related to anaesthesia. Of 12,606 reports over a 2-year period, 2842 (22.5%) resulted in little harm or a moderate degree of harm, and 269 (2.1%) resulted in severe harm or death, with procedure or treatment problems generating the highest risk. One thousand and thirty-five incidents (8%) related to pre-operative assessment, with harm occurring in 275 (26.6%), and 552 (4.4%) related to epidural anaesthesia, with harm reported in 198 (35.9%). Fifty-eight occurrences of anaesthetic awareness were also examined. This preliminary analysis is not authoritative enough to warrant widespread changes of practice, but justifies future collaborative approaches to reduce the potential for harm and improve the submission, collection and analysis of incident reports. Practitioners, departments and professional bodies should consider how the information can be used to promote patient safety and their own defensibility.
Pneumocephalus Following an Accidental Dural Puncture, Treated Using Hyperbaric Oxygen Therapy. A Case Report. [2022]Neuraxial techniques, including epidural anaesthesia, are often used for perioperative pain control and are generally safe. However, both transient, mild and even severe, life-threatening neurologic complications can occur.
Epidural and Spinal Anesthesia for Newborn Surgery. [2020]Neuraxial (spinal and epidural) anesthesia has become commonplace in the care of neonates undergoing surgical procedures. These techniques afford many benefits, and, when properly performed, are extremely safe. This article reviews the benefits, risks, and applications of neuraxial anesthesia in neonates.
Regional and neuraxial anaesthesia techniques for spinal surgery: a scoping review. [2022]Whilst general anaesthesia is commonly used to undertake spine surgery, the use of neuraxial and peripheral regional anaesthesia techniques for intraoperative and postoperative analgesia is an evolving practice. Variations in practice have meant that it is difficult to know which modalities achieve optimal outcomes for patients undergoing spinal surgery. Our objective was to identify available evidence on the use of regional and neuraxial anaesthesia techniques for adult patients undergoing spinal surgery.