Regional Anesthesia for Head and Neck Reconstruction

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Regional Anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fibular free flap-Block performed<br>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<br>* Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively<br>|
| Active Comparator: Anterolateral thigh free flap-Block performed<br>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<br>* Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively<br>|
| Active Comparator: Radial forearm free flap-Block performed<br>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<br>* Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively<br>|
| No Intervention: Fibular free flap -Control<br>No additional procedures beyond the normal standard of care will be performed | |
| No Intervention: Anterolateral thigh free flap-Control<br>No additional procedures beyond the normal standard of care will be performed | |
| No Intervention: Radial forearm free flap-Control<br>No additional procedures beyond the normal standard of care will be performed | |

What is the study measuring?
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Primary Outcome Measures

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