Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

• Status: Terminated
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OhioHealth
• Treatments: Bupivacaine; Ropivacaine

Criteria

Inclusion Criteria:

• Age ≥ 18

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

Exclusion Criteria:

• 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