Regional Anesthesia Block in Fibula Free Flap Reconstruction

July 16, 2019 updated by: University of Florida

Does Regional Anesthesia Reduce Postoperative Opioid Consumption in Subjects Undergoing Fibula Free Flap Reconstruction of the Head and Neck: A Prospective Trial

Despite many recent advances in pain management, post-operative pain is widely considered to be poorly managed. Furthermore, the mainstay of current pain management is opioids, for which there is strong evidence of ill effects and long-term potential for addiction. There are many studies demonstrating that perineural regional anesthesia can be superior to intravenous opioid analgesia, and that the technique is safe. By using temporary implanted catheters, this method can now deliver prolonged analgesia, thus reducing the need for opioids in the postoperative period. Regional anesthesia is a proven technique and used daily by anesthesiologists, and it is also the first choice for hip and knee replacement surgery for orthopedic surgeons. Patients undergoing head and neck reconstruction with the use of free tissue transfer experience a significant amount of post-operative pain due to the complexity of the surgery, the presence of a head and neck surgical site as well as a secondary donor site, and existing co-morbidities, most commonly malignancy, that also cause significant pain. These patients often require opioids for pain control throughout the hospital stay, and are almost always discharged home with additional opioids. By utilizing regional anesthesia blocks at the donor sites, the investigators can potentially reduce post-operative pain while also reducing the use of opioids.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Early Phase 1

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 Health Jacksonville

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 100 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 or secondary reconstruction

Exclusion Criteria:

  • Subjects needing elevation of care to the intensive care unit due to remaining intubated for extended period of time or other complications during the peri or post operative period

  • Subjects with surgical complications requiring significant alteration of the treatment plan

    o Subjects requiring a return to the operating room during admission will be excluded, unless it is for a procedure not related to the original surgery occurring after post op day 3, such as a gastrostomy tube or long term IV access.

  • Subjects with true allergies to the study drugs
  • Subjects undergoing reconstruction with more than 1 free flap, or with the use of any additional regional flaps
  • History of substance dependence or enrollment in a pain management program
  • Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin.
  • Subjects who do not stay in the hospital for at least 4 days post operatively
  • Subjects requiring anticoagulation will not require modifications prior to receiving regional anesthesia.
  • Inability to properly place catheter or administer the regional anesthesia

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regional Nerve Block
Subjects in the regional anesthesia cohort will have a regional anesthesia block and/or catheter placement administered according to current hospital policies and our established standard of care.
Drug: Ropivacaine injection
Regional Anesthesia Nerve Block: Incremental injections up to total of 20 mL of 0.5% ropivacaine is administered.
No Intervention: No Regional Nerve Block
Subjects in the no regional anesthesia cohort will not get pre-operative regional anesthesia, and their surgery and anesthesia will be performed according to normal policies and standard of care in our hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 72 hours (3 days) post-operatively
Defined by the research team as the subjects' morphine equivalent dose at 72 hours (3 days) post-operatively. The 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

January 1, 2020

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201900883

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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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