Suspended

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

What is being tested

Exparel

+ Peripheral Nerve Block

Drug

Who is being recruted

Disease+10

+ Leg Injuries

+ Neurologic Manifestations

Over 18 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: June 2022

See protocol details

Summary

Principal SponsorSt. Luke's Hospital, Pennsylvania

Study ContactAnna Ng-Pellegrino

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2022

Actual date on which the first participant was enrolled.

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.

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

NCT05494645

Principal SponsorSt. Luke's Hospital, Pennsylvania

Study ContactAnna Ng-Pellegrino

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DiseaseLeg InjuriesNeurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesAnkle InjuriesFractures, BoneAnkle Fractures

Criteria

3 inclusion criteria required to participate

Adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution

English speaking

Able to provide consent to surgery and study participation

3 exclusion criteria prevent from participating

Non-elective or emergent foot and ankle surgery

Non-english speaking

Does not possess medical decision making capacity

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

Experimental

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

Group III

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

St. Luke's University Health Network

Bethlehem, United StatesOpen St. Luke's University Health Network in Google Maps

SuspendedOne Study Center