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Completed

NCT Number: NCT05494645

Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery

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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Key information

Conditions

Pain, Postoperative Ankle Fractures Ankle Injuries Ankle Injuries and Disorders Disease Fractures, Bone Leg Injuries Neurologic Manifestations Pain Pain, Acute Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exparel

Drug

Liposomal bupivicaine

Other names: Liposomal bupivicaine

Peripheral Nerve Block

Drug

Peripheral nerve block without Exparel

Other names: marcaine, bupivicaine

Primary outcomes

  1. Duration of block

    Time frame: 1 year

Secondary outcomes

  1. number of opioid pills used by postoperative day # 4

    Time frame: 1 year

  2. PROMIS Scores

    Time frame: 1 year

  3. oral morphine equivalent use by postoperative day 4

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

St. Luke's Hospital, Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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