Buprenorphine for Postoperative Pain After Ankle Fracture Surgery

(BAFA Trial)

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug buprenorphine for postoperative pain after ankle fracture surgery?

Research shows that buprenorphine can provide longer-lasting pain relief and has properties that help manage moderate-to-severe postoperative pain. It has been effective in reducing pain after surgeries, such as lower limb orthopedic and abdominal surgeries, by decreasing the need for other opioids. ^{1 2 3 4 5}

Is buprenorphine safe for use in humans after surgery?

Buprenorphine has been used safely in humans for pain relief after surgery, with low occurrences of side effects like nausea, vomiting, and respiratory depression (breathing problems). It is also noted for its ability to reduce the need for other opioids post-surgery. ^{3 5 6 7 8}

How does the drug buprenorphine differ from other treatments for postoperative pain after ankle fracture surgery?

Buprenorphine is unique because it provides long-lasting pain relief with fewer side effects like nausea and respiratory issues, and it has a ceiling effect on respiratory depression, making it safer at higher doses compared to other pain medications. ^{4 5 6 9 10}

Research Team

Jenna Wilson, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of Epidural Bupivacaine and Buprenorphine to Bupivacaine and Butorphanol for Postoperative Analgesia in Lower Limb Orthopedic Surgery. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Mandatory sublingual buprenorphine for postoperative pain. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Complete opioid transition to sublingual Buprenorphine after abdominal surgery is associated with significant reductions in opioid requirements, but not reduction in hospital length of stay: a retrospective cohort study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Buprenorphine in postoperative pain management. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Effect of Different Doses of Buprenorphine in Combination with Bupivacaine in the Management of Postoperative Analgesia: A Comparative Study. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[The use of buprenorphine for peroperative analgesia]. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Continuation Versus Discontinuation of Buprenorphine in the Perioperative Setting: A Retrospective Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and clinical effectiveness of a compounded sustained-release formulation of buprenorphine for postoperative analgesia in New Zealand White rabbits. [2016]

9. Belgium pubmed.ncbi.nlm.nih.gov

Buprenorphine as postoperative analgesic. [2007]

10. Belgium pubmed.ncbi.nlm.nih.gov

First experience with a new analgesic drug: buprenorphine. [2008]