Status:
RECRUITING
Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery
Lead Sponsor:
Jenna-Leigh Wilson
Collaborating Sponsors:
The Foundation for Barnes-Jewish Hospital
Washington University Institute of Clinical and Translational Sciences
Conditions:
Pain, Postoperative
Ankle Fracture Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, abo...
Detailed Description
Addictive full-agonist opioids, like oxycodone, remain a staple of post-operative analgesia after many types of surgery. However, perioperative exposure to opioid analgesics risks addiction in up to 7...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06949826
Start Date
April 21 2025
End Date
June 1 2027
Last Update
April 29 2025
Active Locations (1)
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1
Washington University in St. Louis/Barnes Jewish Hospital
St Louis, Missouri, United States, 63110