Using nerve blocks for pain management in above-the-knee amputations
Peripheral Nerve Blocks for Upper Leg Amputations
PHASE4 · University of Florida · NCT03404180
This study is testing if using nerve blocks with sedation can help manage pain better for patients having above-the-knee amputations, especially for older adults and those with other health issues.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT03404180 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of peripheral nerve blocks combined with sedation for patients undergoing above-the-knee amputations. It aims to determine if this approach can provide better pain control and safety compared to traditional general anesthesia and opioid therapy, particularly in high-risk populations such as the elderly and those with chronic health conditions. The research will focus on the use of femoral, sciatic, lateral femoral cutaneous, and obturator nerve blocks to achieve surgical anesthesia. The study will involve monitoring postoperative pain scores and analgesic consumption to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for above-the-knee amputation who can provide informed consent.
Not a fit: Patients with severe allergies to local anesthetics or sedatives, those with significant sensorimotor deficits, or those with a BMI of 35 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and safety for high-risk surgical patients.
How similar studies have performed: Other studies have shown promising results with similar nerve block techniques in various surgical settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing above-the-knee amputation or knee disarticulation * Ability to understand and provide informed consent Exclusion Criteria: * Patient refusal or inability to provide informed consent * True allergy, not sensitivity, to any of the following substances: * - Local anesthetics * - Propofol or other sedative agents * - General anesthetic agents * Pregnancy * Severe hepatic impairment * Evidence of infection at or near the proposed needle insertion site * Any sensorimotor deficit, whether acute or chronic, as determined by the PI * Chronic use of opioid medication * BMI ≥ 35
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: José R Soberón, MD — Malcom Randall VA Medical Center
- Study coordinator: Amy M. Gunnett, RN, CCRC
- Email: agunnett@anest.ufl.edu
- Phone: 352-273-8911
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.
Conditions: Peripheral Vascular Diseases, Hyperglycaemia, Hypertension, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive