Regional Anesthesia for Head and Neck Reconstruction

March 17, 2020 updated by: University of Florida

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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
Drug: Regional Anesthesia
Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively
ACTIVE_COMPARATOR: 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
Drug: Regional Anesthesia
Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively
ACTIVE_COMPARATOR: 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
Drug: Regional Anesthesia
Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively
NO_INTERVENTION: Fibular free flap -Control
No additional procedures beyond the normal standard of care will be performed
NO_INTERVENTION: Anterolateral thigh free flap-Control
No additional procedures beyond the normal standard of care will be performed
NO_INTERVENTION: Radial forearm free flap-Control
No additional procedures beyond the normal standard of care will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 72 hours (3 days) post-operatively
Subjects' morphine equivalent dose. Postoperative period commences at extubation.
72 hours (3 days) post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2020

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (ACTUAL)

March 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201903261

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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