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

Sponsor

St. Luke's Hospital, Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05494645

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

15.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Pain, Acute Postoperative Ankle Fractures Ankle Injuries and Disorders	Drug: Exparel Drug: Peripheral Nerve Block	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Masking Description:

patient is blinded to study

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Duration of block [3 Months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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