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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Ankle Fractures; Pain, Acute Postoperative; Ankle Injuries and Disorders
• Intervention / Treatment: Drug: Peripheral Nerve Block; Drug: Exparel

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anna Ng-Pellegrino; Phone Number: 610-954-4000; Email: anna.ngpellegrino@sluhn.org

Study Locations

• United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Recruiting
      • St. Luke's University Health network
      • Contact: Brendan Smith, MD; Phone Number: 484-526-8290; Email: Brendan.smith@sluhn.org
      • Sub-Investigator: Brendan Smith, MD
      • Sub-Investigator: Ajith Malige, MD
      • Principal Investigator: James Lachman, MD
      • Principal Investigator: Anna Ng Pellegrino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peripheral Nerve Block Without Exparel; Lower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine	Drug: Peripheral Nerve Block; Peripheral nerve block without Exparel; Other Names: marcaine, bupivicaine
Experimental: Peripheral Nerve Block with Exparel; Liposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine	Drug: Exparel; Liposomal bupivicaine; Other Names: Liposomal bupivicaine
Experimental: Local Infiltration of Exparel; Liposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% bupivacaine	Drug: Exparel; Liposomal bupivicaine; Other Names: Liposomal bupivicaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of block	3 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
number of opioid pills used by postoperative day # 4	3 months
PROMIS Scores	3 months
oral morphine equivalent use by postoperative day 4	3 months

Collaborators and Investigators

• Sponsor: St. Luke's Hospital, Pennsylvania
• Investigators: Principal Investigator: Anna Ng-Pellegrino, St. Luke's Hospital and Health Network, Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: postoperative pain; liposomal bupivacaine; ankle surgery; regional nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Leg Injuries; Pain, Postoperative; Acute Pain; Ankle Injuries; Ankle Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: SLRI-2022-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No