Using buprenorphine for pain relief after ankle fracture surgery
Official title: A Single-institution, Parallel, Double-blinded, Randomized Study Assessing the Safety and Efficacy of Transdermal Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery
Run by Washington University School of Medicine · NCT06949826 · Data updated 2026-11-12
This study tests if a skin patch with buprenorphine can help manage pain after ankle fracture surgery for patients who haven't used opioids before, while also looking at safety and the risk of addiction.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | April 21, 2025 |
| Main results expected | March 2027 |
| Study ends | June 2027 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT06949826 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking adults aged 18 and older undergoing single-stage open reduction and internal fixation (ORIF) for an ankle fracture.
✕Probably not a fit
Patients with a history of opioid or alcohol use disorder, or those who were taking opioids prior to their injury, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of transdermal buprenorphine as a pain management option for patients undergoing ankle fracture surgery who have not previously used opioids. It aims to assess the safety and effectiveness of buprenorphine in controlling postoperative pain while potentially reducing the risk of opioid addiction. The study will compare the effects of buprenorphine against a placebo patch in a pilot format, setting the groundwork for future research on its impact on opioid dependency. The multidisciplinary team will monitor patient outcomes to evaluate buprenorphine's analgesic properties and safety profile.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the number of patients who develop opioid addiction after surgery.
How similar studies have gone: International studies have shown that transdermal buprenorphine is effective for postoperative pain management, but this specific approach has not been tested in the U.S. population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Washington University in St. Louis/Barnes Jewish Hospital
St Louis, Missouri, United States Recruiting
Study contacts
- Principal investigator: Jenna Wilson, MD — Washington University School of Medicine
- Study coordinator: Noah J Harrison, MD, MMSc
- Email: nharrison@wustl.edu
- Phone: 314-459-1140
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.