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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494645
• Other study ID #: SLRI-2022-24
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: St. Luke's Hospital, Pennsylvania
• Contact: Anna Ng-Pellegrino
• Phone: 610-954-4000
• Email: anna.ngpellegrino[@]sluhn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Exparel
Liposomal bupivicaine
• Peripheral Nerve Block
Peripheral nerve block without Exparel

Locations

Country	Name	City	State
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Hospital, Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of block		3 Months
Secondary	number of opioid pills used by postoperative day # 4		3 months
Secondary	PROMIS Scores		3 months
Secondary	oral morphine equivalent use by postoperative day 4		3 months