RecruitingPhase 4

Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery

United States100 participantsStarted 2025-04-21

Plain-language summary

Addictive full-agonist opioids, like oxycodone and hydrocodone, are often used to treat pain after surgery. However, these full-agonist opioids can be very addictive. After ankle fracture surgery, about 1 in 5 patients that did not take opioids before surgery become addicted to opioids after surgery. Buprenorphine is an opioid with unique properties that may offer a way to reduce the number of patients that become addicted to opioids after surgery. Buprenorphine has good analgesic (painkilling) effects. It is also thought to be less addictive and cause less of a high than full-agonist opioids, like oxycodone and hydrocodone. This project's goal is to determine if transdermal buprenorphine can safely and effectively control pain after ankle fracture surgery. This study will be a pilot study, which sets the stage for future studies that investigate whether buprenorphine can reduce the rate that patients become addicted to opioids after surgery. This study's multidisciplinary team will divide patients into two groups. Participants in one group will be treated with a 7-day transdermal buprenorphine patch (where the buprenorphine is slowly absorbed through the skin over 7 days). Participants in the other group will be treated with a placebo patch. A placebo has no drug in it, it just looks like the buprenorphine patch. Aside from the buprenorphine patch or placebo patch, both groups' pain management plans will be the same as if they were not in the study. Over the first week after surgery, the investigators will measure the amount of full-agonist opioids (for example, oxycodone or hydrocodone) that participants consume, participants' pain scores, the frequency of side effects related to opioids, and the number of calls and patient portal messages to the clinic for uncontrolled pain. The investigators will also assess whether participants are continuing to use opioids 3 months after surgery for pain related to their ankle fracture.

Who can participate

Age range18 Years

SexALL

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: * Patient is 18 years of age or older * Patient is undergoing single stage ORIF of an ankle fracture * Patient is English-speaking EXCLUSION CRITERIA: * Patient is under 18 years of age * Patient's ankle fracture is treated with external fixation * Patient has a concomitant osseous or visceral injury * Patient has a history of opioid use disorder or a current diagnosis of opioid use disorder * Patient has a history of alcohol use disorder or a current diagnosis of alcohol use disorder * Patient was taking opioid medication or narcotic drugs prior to their injury * Patient has a current active malignancy * Patient is taking a medication that carries a prohibitively high risk of drug-drug interaction with buprenorphine, hydrocodone, or oxycodone in the view of their treating physician or nurse anesthetist * Patient has an anaphylactic allergy to buprenorphine, hydrocodone, or oxycodone * Patient is not English-speaking * Patient is pregnant * Patient is unable to complete pain diary or communicate pain scores * Patient is incarcerated * Patient has a Gustilo-Anderson Type III open fracture

What they're measuring

Morphine Milligram Equivalents of Full-agonist Opioid Consumed

Timeframe: Post-operative days 0-7. First post-operative clinic visit (approximately 3 weeks after surgery).

Trial details

NCT IDNCT06949826

SponsorJenna-Leigh Wilson

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Noah J Harrison, MD, MMSc

314-459-1140 nharrison@wustl.edu