Regional Anesthesia for Head and Neck Reconstruction

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04304716
• Other study ID #: IRB201903261
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2020
• Est. completion date: March 2021

Study information

• Verified date: March 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Regional Anesthesia
Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively

Locations

Country	Name	City	State
United States	University of Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Subjects' morphine equivalent dose. Postoperative period commences at extubation.	72 hours (3 days) post-operatively