Phase 4
N=100
Regional Block for Postoperative Free Flap Care
Pain Management
Bottom Line
View on ClinicalTrials.gov: NCT04080739 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Opioid Utilization Measured in Oral Morphine Equivalent (OME) — 118; 166 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ropivicaine 0.2% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Utilization Measured in Oral Morphine Equivalent (OME) |
118; 166 | — |
| SECONDARY Opioid Medication Use |
118; 166 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04080739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.