Buprenorphine for Postoperative Pain After Ankle Fracture Surgery

(BAFA Trial)

Recruiting at 1 trial location

Overseen By Noah J Harrison, MD, MMSc

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Jenna-Leigh Wilson

Must not be taking: Opioids, Narcotics

Disqualifiers: Opioid use disorder, Alcohol use disorder, Active malignancy, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 1 week

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a buprenorphine patch can safely and effectively manage pain after ankle fracture surgery, aiming to reduce opioid addiction. Buprenorphine may provide effective pain relief while being less addictive than common painkillers like oxycodone. Participants will receive either a buprenorphine patch or a placebo patch, with all other care remaining standard. This trial suits individuals undergoing surgery to repair a broken ankle who have not previously used opioids. As a Phase 4 trial, this research seeks to understand how the already FDA-approved buprenorphine patch benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking a medication that could dangerously interact with buprenorphine, hydrocodone, or oxycodone, you may not be eligible to participate.

What is the safety track record for buprenorphine?

Research has shown that buprenorphine in patch form is safe for pain relief after surgery. Patients using the patch report only minor side effects, such as mild nausea and vomiting, which are common with many painkillers. Importantly, the patch does not cause serious breathing problems, a risk associated with some other opioids.

This treatment has been tested on people before, and results suggest it is a safe option for managing post-surgical pain. Designed to be less addictive than other strong painkillers like oxycodone and hydrocodone, it offers a promising choice for those concerned about addiction after surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Buprenorphine is unique for postoperative pain after ankle fracture surgery because it is administered via a transdermal patch, offering a convenient and non-invasive delivery method. Unlike traditional oral pain medications, which often include opioids like oxycodone or hydrocodone, this patch provides a steady release of pain relief, potentially reducing the need for frequent dosing and minimizing the risk of overdose. Researchers are excited because buprenorphine, as a partial opioid agonist, may offer effective pain management with a lower potential for addiction and fewer side effects compared to full opioid agonists, making it a promising alternative in postoperative care.

What evidence suggests that buprenorphine might be an effective treatment for postoperative pain after ankle fracture surgery?

Research has shown that buprenorphine effectively manages pain after surgery. In this trial, one group of participants will receive the buprenorphine transdermal patch, which studies have found provides good pain relief with few side effects. This patch is considered a good option for pain management, especially in surgeries involving bones, like ankle fractures. Buprenorphine is also believed to be less addictive than other painkillers, such as oxycodone and hydrocodone. This characteristic may help reduce the risk of addiction after surgery while still effectively controlling pain. ^{3 5 6 7 8}

Who Is on the Research Team?

Jenna Wilson, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for opioid-naive patients who have undergone ankle fracture surgery and are at risk of developing an addiction to opioids. Participants should not have a history of opioid dependence or use disorder, and must be willing to follow the postoperative pain management plan.

Inclusion Criteria

Patient is English-speaking

I am having surgery to fix my broken ankle with plates and screws.

Exclusion Criteria

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 has an anaphylactic allergy to buprenorphine, hydrocodone, or oxycodone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 7-day transdermal buprenorphine patch or placebo patch for post-operative analgesia

1 week

1 visit (in-person) for patch application

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and opioid consumption

3 months

Multiple visits (in-person and virtual) at post-operative days 7, 21, and 90

Long-term Follow-up

Participants are assessed for persistent opioid use and post-operative complications

Up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Buprenorphine

Trial Overview The study tests if a buprenorphine transdermal patch can manage pain effectively after ankle surgery without leading to addiction. Patients will either receive this patch or a placebo, with both groups following the same overall pain management strategy.

How Is the Trial Designed?

Group I: Buprenorphine Transdermal System Experimental Treatment 1 Intervention

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.

Group II: Placebo Patch Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Jenna-Leigh Wilson

Lead Sponsor

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+

Washington University Institute of Clinical and Translational Sciences

Collaborator

Trials

2

Recruited

240+

Citations

1. withpower.com withpower.com/trial/phase-4-fractures-bone-3-2025-0de39

Buprenorphine for Postoperative Pain After Ankle Fracture ... This project's goal is to determine if transdermal buprenorphine can safely and effectively control pain after ankle fracture surgery.

2. trial.medpath.com trial.medpath.com/clinical-trial/afb2f325c46fba8f/transdermal-buprenorphine-postoperative-analgesic-ankle-fracture

Buprenorphine as a Post-operative Analgesic in Opioid-Naive ... This project's goal is to determine if transdermal buprenorphine can safely and effectively control pain after ankle fracture surgery. This ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40447820/

Transdermal buprenorphine patch in the management of ... Transdermal buprenorphine is a viable alternative for post-operative pain management in orthopaedic patients, especially the elderly.

4. journals.lww.com journals.lww.com/joacp/fulltext/2021/04000/comparative_evaluation_of_analgesic_efficacy_of.21.aspx

Comparative evaluation of analgesic efficacy of... Buprenorphine patch (20 μg·h -1 ) applied 12 h prior to surgery is an effective postoperative analgesic and it is not associated with any significant adverse ...

5. researchgate.net researchgate.net/publication/321132286_Efficacy_of_transdermal_buprenorphine_patch_on_post-operative_pain_relief_after_elective_spinal_instrumentation_surgery

(PDF) Efficacy of transdermal buprenorphine patch on post ... The aim of this study was to evaluate the analgesic efficacy of buprenorphine patch for postoperative pain relief in patients undergoing spinal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5703007/

Efficacy of transdermal buprenorphine patch on post-operative ... A TDB patch (10 μg/hour) applied 24 hours before surgery can be used as a postoperative analgesic for lumber fixation surgery without any drug-related adverse ...

7. jpain.org jpain.org/article/S1526-5900(23)00465-0/fulltext

Efficacy and Safety of Transdermal Buprenorphine for ... They conclude that TBUP seems to be an effective and safe option for postoperative pain. However, we did not come to this conclusion as the ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023004650

Efficacy and Safety of Transdermal Buprenorphine for ... There is insufficient evidence that TBUP improves pain control compared to other analgesics for acute postoperative pain.