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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJenna-Leigh Wilson

About this trial

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.

Eligibility criteria

Qualifiers

Patient is 18 years of age or older

Patient is undergoing single stage ORIF of an ankle fracture

Patient is English-speaking

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Buprenorphine Transdermal System
  • Placebo Patch

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Jenna-Leigh Wilson

Lead sponsor

Washington University School of Medicine

Sponsor institution

The Foundation for Barnes-Jewish Hospital

Collaborator

Washington University Institute of Clinical and Translational Sciences

Collaborator