Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial

Study Overview
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Brief Summary
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Liposomal Bupivacaine (Exparel) has been recently studied as the active agent utilized in various nerve block. Due to its liposomal form allowing for extended delivery, Exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and decreased opioid use. This study compares the efficacy and effect on opioid use of peripheral nerve blocks and local infiltration with and without Exparel in patients undergoing foot and ankle surgery.

Detailed Description
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three study groups: A - surgeon infiltrates with exparel on site of surgery; B - anesthesia provides a regional nerve block (popliteal/adductor blocks) with plain local anesthetic (bupivacaine); C - anesthesia provides a regional nerve block (popliteal/adductor) with Exparel/bupivacaine mix. Follow up occurs on postop day 4 via phone call to patient. Measured outcomes include opioid consumption in post anesthesia care unit phase (oral morphine equivalents), block duration, number of opioid pills used by postop day 4, oral morphine equivalent consumption by postop day 4.

Official Title
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Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial

Conditions
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Pain, Postoperative, Pain, Acute Postoperative, Ankle Fractures, Ankle Injuries and Disorders

Intervention / Treatment
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* Drug: Exparel
* Drug: Peripheral Nerve Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution English speaking Able to provide consent to surgery and study participation Exclusion Criteria: Non-elective or emergent foot and ankle surgery Non-english speaking Does not possess medical decision making capacity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peripheral Nerve Block Without Exparel<br>Lower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine | Drug: Peripheral Nerve Block<br>* Peripheral nerve block without Exparel<br>* Other names: marcaine, bupivicaine;|
| Experimental: Peripheral Nerve Block with Exparel<br>Liposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine | Drug: Exparel<br>* Liposomal bupivicaine<br>* Other names: Liposomal bupivicaine;|
| Experimental: Local Infiltration of Exparel<br>Liposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% bupivacaine | Drug: Exparel<br>* Liposomal bupivicaine<br>* Other names: Liposomal bupivicaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of block |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of opioid pills used by postoperative day # 4 |  | 3 months | 
| PROMIS Scores |  | 3 months | 
| oral morphine equivalent use by postoperative day 4 |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liposomal bupivacaine, ankle surgery, postoperative pain, regional nerve block