Status:
COMPLETED
Peripheral Nerve Blocks for Above-the-knee Amputations
Lead Sponsor:
University of Florida
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Peripheral Vascular Diseases
Hyperglycaemia (Diabetic)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and tro...
Detailed Description
Avoidance of general anesthesia in certain high-risk patient populations may have additional benefits beyond improved postoperative pain scores and analgesic consumption. The primary objective of this...
Eligibility Criteria
Inclusion
- Patients undergoing above-the-knee amputation or knee disarticulation
- Ability to understand and provide informed consent
Exclusion
- 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
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03404180
Start Date
February 9 2018
End Date
December 18 2024
Last Update
January 8 2026
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32611