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

St. Luke's Hospital, Pennsylvania

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Peripheral Nerve Block; Drug: Exparel

Study type: Interventional

Funder types: Other

Identifiers

NCT05494645

SLRI-2022-24

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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300 participants in 3 patient groups

Peripheral Nerve Block Without Exparel

Active Comparator group

Description:

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

Treatment:

Drug: Peripheral Nerve Block

Peripheral Nerve Block with Exparel

Experimental group

Description:

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

Treatment:

Drug: Exparel

Local Infiltration of Exparel

Experimental group

Description:

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

Treatment:

Drug: Exparel