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Clinical Trials/NCT04304716
NCT04304716
Withdrawn
Phase 4

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

University of Florida1 site in 1 countryMarch 2020

Overview

Phase
Phase 4
Intervention
Regional Anesthesia
Conditions
Pain, Postoperative
Sponsor
University of Florida
Locations
1
Primary Endpoint
Opioid consumption
Status
Withdrawn
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2020
End Date
March 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Fibular free flap-Block performed

For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed

Intervention: Regional Anesthesia

Anterolateral thigh free flap-Block performed

Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed

Intervention: Regional Anesthesia

Radial forearm free flap-Block performed

Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed

Intervention: Regional Anesthesia

Outcomes

Primary Outcomes

Opioid consumption

Time Frame: 72 hours (3 days) post-operatively

Subjects' morphine equivalent dose. Postoperative period commences at extubation.

Study Sites (1)

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