Recruiting

Buprenorphine

Sponsor:

Jenna-Leigh Wilson

Code:

NCT06949826

Conditions

Pain, Postoperative

Ankle Fracture Surgery

Opioid Use Disorder

Opioid Dependence

Opioid Analgesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Buprenorphine Transdermal System

Placebo Patch

Study Details

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, 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.

Conditions

Pain, Postoperative

Ankle Fracture Surgery

Opioid Use Disorder

Opioid Dependence

Opioid Analgesia

Study ID

NCT06949826

Start date

Apr 21, 2025

Status verified date

Mar, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Buprenorphine Transdermal System

Participants in this arm will be treated with the transdermal buprenorphine system (a transdermal patch) that is applied in the pre-operative holding area. Aside from being treated with the transdermal buprenorphine system, their care will otherwise be in accordance with the standard of care following ankle fracture surgery.

placebo comparator: Placebo Patch

Participants in this arm will be treated with a placebo patch that is applied in the pre-operative holding area. Aside from the placebo patch, their care will otherwise be in accordance with the standard of care following ankle fracture surgery.

Interventions

Buprenorphine 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.

Placebo 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.

Primary outcome measure

  • Morphine Milligram Equivalents of Full-agonist Opioid Consumed [ Time Frame: Post-operative days 0-7. First post-operative clinic visit (approximately 3 weeks after surgery). ]

Central Contacts and Locations

Central contacts

Noah J Harrison, MD, MMSc

314-459-1140nharrison@wustl.edu

Juanita Taylor, MPA, BS, RRT

314-454-7047jrtaylor@wustl.edu

Locations

Washington University in St. Louis/Barnes Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Noah J Harrison, MD, MMSc

314-459-1140nharrison@wustl.edu

Juanita R Tylor, MPA, BS, RRT

314-454-7047jrtaylor@wustl.edu

Principal Investigator:

Jenna L Wilson, MD

More Information

Sponsor

Jenna-Leigh Wilson

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Keywords

  • Buprenorphine
  • Postoperative pain
  • Transdermal buprenorphine
  • Ankle fracture surgery
  • Ankle fracture
  • Opioid-naive patient
  • ORIF Ankle Fracture
  • Opioid use disorder
  • Opioid Addiction
  • Buprenorphine for postoperative pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jenna-Leigh Wilson on 2026-04-06.