Status:
COMPLETED
Regional Block for Postoperative Free Flap Care
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Pain Management
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia for head and neck patients undergoing microvascular free flap reconstruction.
Detailed Description
The increasing rate of opioid related overdose mortality is well documented in the literature and approached 15 per 100,000 in 2017. Because of a growing epidemic in the US, the medical community is u...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age \> 18
- Able to consent for themselves
- Undergoing a head and neck surgery at UAB with reconstruction using either a forearm free flap or a fibula free flap
- Exclusion criteria:
- Age \< 18
- Unable to consent for themselves
- Non-English speakers
- Non-resectable tumor
- Have a known opioid tolerance, or are on a home opioid regimen for a chronic condition. (Short-term opioid use for diagnostic procedures (i.e. biopsy) or new cancer diagnosis will be allowed).
- Patients with known hepatic failure, renal failure, or sulfa allergy, as determined by standard of care labs drawn within 30 days of enrollment
Exclusion
Key Trial Info
Start Date :
January 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04080739
Start Date
January 13 2020
End Date
March 1 2022
Last Update
December 6 2023
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233