NCT02499575

Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: OhioHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Bunion
• Hallux Rigidus

Interventions

Type	Name	Description
DRUG	0.5% ropivacaine	Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
DRUG	Exparel	106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-01-01
• Completion: 2016-07-01
• First posted: 2015-07-16
• Last updated: 2017-05-17
• Results posted: 2017-05-17

Locations

2 sites across 1 country: United States