Back to resultsRegional Anesthesia for Head and Neck Reconstruction
Primary Purpose
Pain, Postoperative
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Regional Anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
No Intervention
No Intervention
Arm Label
Fibular free flap-Block performed
Anterolateral thigh free flap-Block performed
Radial forearm free flap-Block performed
Fibular free flap -Control
Anterolateral thigh free flap-Control
Radial forearm free flap-Control
Arm 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
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
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
No additional procedures beyond the normal standard of care will be performed
No additional procedures beyond the normal standard of care will be performed
No additional procedures beyond the normal standard of care will be performed
Outcomes
Primary Outcome Measures
Opioid consumption
Subjects' morphine equivalent dose. Postoperative period commences at extubation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04304716
Brief Title
Regional Anesthesia for Head and Neck Reconstruction
Official Title
Regional Anesthesia for the Management of Perioperative Pain for Free Flap Reconstruction of the Head and Neck: A Randomized Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn from the IRB
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fibular free flap-Block performed
Arm Type
Active Comparator
Arm 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
Arm Title
Anterolateral thigh free flap-Block performed
Arm Type
Active Comparator
Arm Description
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
Arm Title
Radial forearm free flap-Block performed
Arm Type
Active Comparator
Arm Description
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
Arm Title
Fibular free flap -Control
Arm Type
No Intervention
Arm Description
No additional procedures beyond the normal standard of care will be performed
Arm Title
Anterolateral thigh free flap-Control
Arm Type
No Intervention
Arm Description
No additional procedures beyond the normal standard of care will be performed
Arm Title
Radial forearm free flap-Control
Arm Type
No Intervention
Arm Description
No additional procedures beyond the normal standard of care will be performed
Intervention Type
Drug
Intervention Name(s)
Regional Anesthesia
Intervention Description
Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively
Primary Outcome Measure Information:
Title
Opioid consumption
Description
Subjects' morphine equivalent dose. Postoperative period commences at extubation.
Time Frame
72 hours (3 days) post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Fernandes, MD, DMD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Regional Anesthesia for Head and Neck Reconstruction
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