Regional Anesthesia for Head and Neck Reconstruction

Phase 4

Withdrawn

• Conditions: Pain, Postoperative
• Interventions: Drug: Regional Anesthesia

• Registration Number: NCT04304716
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-11
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anterolateral thigh free flap-Block performed	Regional Anesthesia	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
Fibular free flap-Block performed	Regional Anesthesia	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
Radial forearm free flap-Block performed	Regional Anesthesia	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

Primary Outcome Measures

Name	Time	Method
Opioid consumption	72 hours (3 days) post-operatively	Subjects' morphine equivalent dose. Postoperative period commences at extubation.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Jacksonville, Florida, United States