TerminatedNot Applicable

Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

Stopped: Logistical issues prevent efficient enrollment

United States2 participantsStarted 2015-07

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Opioid Use as Measured by Questionnaire

Timeframe: Daily through the third day (72 hours) post-surgery

Total Opioid Use as Measured by Questionnaire

Timeframe: Daily through the third day (72 hours) post-surgery

Trial details

NCT IDNCT02499575

SponsorOhioHealth

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

Results submitted2016-11-30

View on ClinicalTrials.gov More Bunion trials