RecruitingPhase 4NCT06949826

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

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

Sponsor

Jenna-Leigh Wilson

Enrollment

100 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

Pain, Postoperative Ankle Fracture Surgery

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, 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

Min Age: 18 Years

Inclusion Criteria3

Patient is 18 years of age or older
Patient is undergoing single stage ORIF of an ankle fracture
Patient is English-speaking

Exclusion Criteria14

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

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Interventions

DRUGBuprenorphine Transdermal System

The buprenorphine transdermal system is unique from other interventions in the study, as it is the experimental drug in the study. The buprenorphine transdermal system will be applied in the pre-operative holding area. Aside from the buprenorphine transdermal system, participants assigned to this intervention will otherwise receive the standard of care in their post-operative pain management following ankle fracture surgery.

DRUGPlacebo Patch

The placebo patch is unique from other interventions in the study, as it is the placebo drug in the study. The placebo patch will be applied in the pre-operative holding area. Aside from the placebo patch, participants assigned to this intervention will otherwise receive the standard of care in their post-operative pain management following ankle fracture surgery.