NCT05494645

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: St. Luke's Hospital, Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

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

Interventions

Type	Name	Description
DRUG	Exparel	Liposomal bupivicaine
DRUG	Peripheral Nerve Block	Peripheral nerve block without Exparel

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-06-01
• Completion: 2023-12-31
• First posted: 2022-08-10
• Last updated: 2022-08-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study