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

Phase 4

• Conditions: Pain, Postoperative; Pain, Acute Postoperative; Ankle Fractures; Ankle Injuries and Disorders
• Interventions: Drug: Peripheral Nerve Block; Drug: Exparel

• Registration Number: NCT05494645
• Lead Sponsor: St. Luke's Hospital, Pennsylvania

Brief 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.

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2022-07
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Peripheral Nerve Block Without Exparel	Peripheral Nerve Block	Lower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine
Peripheral Nerve Block with Exparel	Exparel	Liposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine
Local Infiltration of Exparel	Exparel	Liposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% bupivacaine

Primary Outcome Measures

Name	Time	Method
Duration of block	3 Months

Secondary Outcome Measures

Name	Time	Method
oral morphine equivalent use by postoperative day 4	3 months
number of opioid pills used by postoperative day # 4	3 months
PROMIS Scores	3 months

Trial Locations

Locations (1)

St. Luke's University Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States