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

Last updated: August 8, 2022
Sponsor: St. Luke's Hospital, Pennsylvania
Overall Status: Active - Recruiting

Phase

4

Condition

Acute Pain

Pain

Treatment

N/A

Clinical Study ID

NCT05494645
SLRI-2022-24
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients undergoing elective orthopaedic foot and ankle surgery at a singleinstitution
  • English speaking
  • Able to provide consent to surgery and study participation

Exclusion

Exclusion Criteria:

  • Non-elective or emergent foot and ankle surgery
  • Non-english speaking
  • Does not possess medical decision making capacity

Study Design

Total Participants: 300
Study Start date:
June 01, 2022
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania 18015
    United States

    Active - Recruiting

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