Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

Stopped early · Not applicable

Conditions studied: Bunion, Hallux Rigidus

In brief

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).

Key facts

Study ID

NCT02499575

Run by

OhioHealth

People needed

2

Starts

2015-07-01

Expected to finish

2016-07-01

Last updated by the study team

2017-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18
• Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy

You may not qualify if…

• Age less than 18
• Unable to read/write English
• Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
• Weight <70 kg
• Allergy to local anesthetics
• History of long-acting opioid use or opioid tolerance (any patient receiving at least 30 mg of oxycodone or equivalent per day (e.g., 6 tabs of Percocet 5/325 mg) regularly for approximately 7 days or more OR who require increased analgesic doses for a period long enough to develop tolerance to the effects of the opioid including analgesia and sedation)
• Any history of opioid misuse, illicit or prescription
• Prior MTP joint correction on the surgical limb
• Midfoot and hindfoot procedures performed concurrently, on the same day
• Pregnant or breastfeeding

Where it is running

• Grant Medical Center — Columbus, Ohio, United States
• Orthopedic Foot and Ankle Center — Westerville, Ohio, United States

Full record on ClinicalTrials.gov

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