Study of Transdermal Buprenorphine for Pain Relief After Ankle Fracture Surgery In Adults Who Have Not Used Opioids Before Surgery

What this Trial Is About

Researchers are investigating the use of buprenorphine, a partial opioid, to control pain after ankle fracture surgery in patients who have not previously taken opioids. The study aims to see if buprenorphine can reduce the use and addiction risk of full-agonist opioids like oxycodone and hydrocodone, which are commonly used but highly addictive. This pilot study is an important step toward safer post-operative pain management given the high rate of opioid dependence after surgery and the opioid epidemic in the United States. Participants will be randomly assigned to one of two groups. One group will receive a 7-day transdermal buprenorphine patch applied before surgery, while the other group will receive a placebo patch that looks the same but contains no drug. Both groups will otherwise follow standard pain management care after ankle fracture surgery. The study will monitor how much full-agonist opioid each participant uses, their reported pain levels, and side effects during the first week after surgery. Throughout the study, investigators will collect detailed information including pain scores, opioid consumption, episodes of breakthrough pain, and calls or messages to the clinic about uncontrolled pain. They will also monitor adverse effects related to opioid use, hospital readmissions, emergency visits, and opioid toxicity up to three months after surgery. The main outcome is the amount of full-agonist opioid used in the first week post-surgery. This thorough monitoring will help assess the safety and effectiveness of buprenorphine for post-operative pain management and its potential to reduce opioid dependence.

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