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

NCT05494645 | Completed Phase 4 FDA Drug

• 1 other identifier: SLRI-2022-24
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

liposomal bupivacaine; ankle surgery; postoperative pain; regional nerve block

Outcome Measures

Primary Outcomes (1)

• Duration of block

  1 year

Secondary Outcomes (3)

• number of opioid pills used by postoperative day # 4

  1 year

• PROMIS Scores

  1 year

• oral morphine equivalent use by postoperative day 4

  1 year

Study Arms (3)

Peripheral Nerve Block Without Exparel

ACTIVE COMPARATOR

Lower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine

Drug: Peripheral Nerve Block

Peripheral Nerve Block with Exparel

EXPERIMENTAL

Liposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine

Drug: Exparel

Local Infiltration of Exparel

EXPERIMENTAL

Liposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% bupivacaine

Drug: Exparel

Interventions

Exparel DRUG

Liposomal bupivicaine

Also known as: Liposomal bupivicaine

Local Infiltration of Exparel; Peripheral Nerve Block with Exparel

Peripheral Nerve Block DRUG

Peripheral nerve block without Exparel

Also known as: marcaine, bupivicaine

Peripheral Nerve Block Without Exparel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Luke's Hospital, Pennsylvania: lead

Study Sites (1)

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Ankle Fractures; Ankle Injuries; Disease

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Anna Ng-Pellegrino

  St. Luke's Hospital and Health Network, Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patient is blinded to study
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: March 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 28, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)