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Regional Anesthesia for Head and Neck Reconstruction

Regional Anesthesia for the Management of Perioperative Pain for Free Flap Reconstruction of the Head and Neck: A Randomized Prospective Trial

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04304716
Enrollment
0
Registered
2020-03-11
Start date
2020-03-31
Completion date
2021-03-31
Last updated
2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Brief summary

By utilizing regional anesthesia blocks at the surgery tissue donor sites, it can potentially reduce post-operative pain while also reducing the use of opioids. It can aim to measure the reduction in opioid use, reduction in pain scores, patient satisfaction, and because there is not a current protocol established for regional anesthesia use for free flap reconstruction, and we aim to standardize the procedure.

Interventions

DRUGRegional Anesthesia

Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Subjects undergoing microvascular fibula free flap reconstruction of the head and neck * Subjects undergoing primary reconstruction for both benign and malignant etiology

Exclusion criteria

* Pregnant women * Subjects with true allergies to the study drugs, reporting anaphylaxis in the past * Subjects undergoing reconstruction with more than 1 free flap * Subjects undergoing secondary reconstructions * Subjects undergoing surgery for osteonecrosis * History of enrollment in a pain management program * Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin

Design outcomes

Primary

MeasureTime frameDescription
Opioid consumption72 hours (3 days) post-operativelySubjects' morphine equivalent dose. Postoperative period commences at extubation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026