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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Jenna-Leigh Wilson
Study ID
NCT06949826
Phase
PHASE4
Status
Recruiting
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Conditions

  • Ankle Fracture Surgery
  • Opioid Analgesia
  • Opioid Dependence
  • Opioid Use Disorder
  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Buprenorphine Transdermal System — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 21, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in St. Louis/Barnes Jewish HospitalSt LouisMissouri63110
Noah J Harrison, MD, MMSc
[email protected]
314-459-1140
Juanita R Tylor, MPA, BS, RRT
[email protected]
314-454-7047
Jenna L Wilson, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Washington University in St. Louis/Barnes Jewish Hospital· St Louis, MO

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