Evaluating anesthesia types for lower limb surgery
Anesthesia for Lower Limb Revascularization to Optimize Functional ouTcomes
This study is trying to see if using different types of anesthesia during lower limb surgery can improve recovery for adults who are scheduled for these procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06067789 on ClinicalTrials.gov |
What this trial studies
The ALOFT Pilot Trial aims to assess the feasibility of a larger trial comparing neuraxial and general anesthesia for lower limb revascularization surgery. It will focus on three key elements: recruitment, adherence, and follow-up, using implementation science methodologies to refine processes. The trial will involve participants aged 18 and older who are scheduled for specific surgical procedures. This pilot study will help establish the groundwork for a multicenter, randomized controlled trial to evaluate the effectiveness of anesthesia types in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective or urgent lower limb revascularization surgery.
Not a fit: Patients with contraindications to neuraxial anesthesia or those with specific medical conditions such as multiple sclerosis or pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to improved anesthesia practices that enhance recovery and outcomes for patients undergoing lower limb surgery.
How similar studies have performed: Previous studies have suggested benefits of neuraxial anesthesia, but this approach is novel in its rigorous multicenter, randomized design focused on patient-reported outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years 2. Planned lower limb revascularization surgical procedure (on an elective or urgent basis): infrainguinal arterial bypass, femoral endarterectomy, patch angioplasty 3. Able to access a telephone for postoperative follow-up Exclusion Criteria: 1. Absolute contraindications to neuraxial anesthesia: impaired coagulation state (due to intrinsic, congenital or extrinsic (i.e., anticoagulant not held for guideline recommended period based on the American Society of Regional Anesthesia recommendations) factors), infection at the needle insertion point, increased intracranial pressure or intracranial mass, uncorrected hypovolemia or hypotension (systolic blood pressure \<90 mmHg), severe uncorrected aortic stenosis) 2. Traumatic arterial injuries as an indication for surgery 3. Multiple sclerosis or demyelinating central nervous system conditions 4. Known malignant hyperthermia or who require a malignant hyperthermia trigger-free anesthetic 5. Pregnancy 6. Prior enrollment in this study, or participating in another interventional trial that could interfere with interpretation of data for either study (may be acceptable if unrelated interventions/outcomes and study PIs mutually agree in writing to co-enrollment) 7. Determination by the surgeon, anesthesiologist, or other clinician, that the patient would not be suitable for randomization
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Daniel McIsaac, MD — The Ottawa Hospital
- Study coordinator: Emily Hladkowicz, PhD (c)
- Email: emhladkowicz@toh.ca
- Phone: 613-798-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.