Regional Anesthesia Block in Fibula Free Flap Reconstruction

Early Phase 1

Withdrawn

• Conditions: Anesthesia, Local; Surgery; Opioid Use; Pain, Postoperative; Head and Neck Neoplasms
• Interventions: Drug: Ropivacaine injection

• Registration Number: NCT03906838
• Lead Sponsor: University of Florida

Brief Summary

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.

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

• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-18
• Study Start: 2020-01-01
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30

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• Status: WITHDRAWN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 or secondary reconstruction

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regional Nerve Block	Ropivacaine injection	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.

Primary Outcome Measures

Name	Time	Method
Opioid consumption	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.

Trial Locations

Locations (1)

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