Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

Hallux Rigidus Clinical Trial

Official title: Exparel Pericapsular Injection: A Prospective Evaluation of Postoperative Pain in Bunion Surgery, First Metatarsophalangeal Joint Fusion, and Cheilectomy

Status Terminated

Clinical Trial Summary

Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).

Clinical Trial Description

The investigators propose a prospective, randomized, single-blinded study of patients who are electing to undergo an outpatient first metatarsophalangeal (MTP) joint procedure (bunionectomy, 1st MTP fusion, or cheilectomy). As a standard, patients undergoing these procedures are given regional anesthesia (adductor canal block plus popliteal block). Patients are then given prescriptions for oral opioids to manage post-operative pain. The purpose of this study is to determine whether a single intrapopliteal administration of Exparel, in conjunction with the standard of care regional block, improves pain relief and therefore decreases use of post-operative opioids. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bunion
• Hallux Limitus
• Hallux Rigidus
• Hallux Valgus

• NCT number: NCT02499575
• Study type: Interventional
• Source: OhioHealth
• Status: Terminated
• Phase: N/A
• Start date: July 2015
• Completion date: July 2016