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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-12-31

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

patient is blinded to study

Study Groups

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Peripheral Nerve Block Without Exparel

Lower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine

Group Type ACTIVE_COMPARATOR

Peripheral Nerve Block

Intervention Type DRUG

Peripheral nerve block without Exparel

Peripheral Nerve Block with Exparel

Liposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine

Group Type EXPERIMENTAL

Exparel

Intervention Type DRUG

Liposomal bupivicaine

Local Infiltration of Exparel

Liposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% bupivacaine

Group Type EXPERIMENTAL

Exparel

Intervention Type DRUG

Liposomal bupivicaine

Interventions

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Exparel

Liposomal bupivicaine

Intervention Type DRUG

Peripheral Nerve Block

Peripheral nerve block without Exparel

Intervention Type DRUG

Other Intervention Names

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Liposomal bupivicaine marcaine, bupivicaine

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