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

Launched by JENNA-LEIGH WILSON · Apr 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of buprenorphine, a type of pain medication, as a way to manage pain after ankle fracture surgery. Traditional pain medications like oxycodone can be very addictive, and about 20% of patients who have not used opioids before surgery may become addicted afterwards. Buprenorphine is believed to be less addictive and still effective for pain relief. The goal of this trial is to see if a skin patch that delivers buprenorphine over a week can help control pain safely and reduce the risk of addiction.

To be eligible for this study, participants need to be at least 18 years old, have a specific type of ankle fracture that requires surgery, and be able to speak English. The study involves two groups: one will receive the buprenorphine patch, while the other will receive a placebo patch that doesn’t contain any medication. Both groups will follow the same pain management plan as others who undergo the surgery. Participants will be monitored for their pain levels and any side effects for the first week after surgery, and their use of opioids will be assessed three months later. This study is important as it may help find safer ways to manage post-surgery pain and reduce the risk of opioid addiction.

Gender

ALL

Eligibility 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