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

NCT06949826 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 202406162
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (7)

• Visual Analog Pain Scores

  After surgery, visual analog pain scores with movement and at rest will be reported by the patient in a pain diary. In admitted patients, visual analog pain scores will be recorded by the bedside nurse. Visual analog pain scores are rated from 0-10. A score of 0 represents that the patient has no pain. A score of 10 represents excruciating pain.

  Postoperative days 1-8, 21, 90.

• Morphine Milligram Equivalents of Full-agonist Opioid Consumed

  After surgery, patients will record the total amount of opioid medication they consumed during the first post-operative week in their pain diary. In admitted patients, the electronic medical record will be reviewed to determine the morphine milligram equivalents of opioid consumed while admitted. Patients will also bring all their bottles and opioid prescriptions to their first post-operative clinic visit, at which point their total opioid consumption between surgery and their first post-operative clinic visit will be recorded by the researchers.

  Post-operative days 0-7. First post-operative clinic visit (approximately 3 weeks after surgery).

• Hospital Readmissions due to Opioid Toxicity

  The researchers will track the number of hospital readmissions secondary to opioid toxicity.

  From patch application to post-operative day 21

• Emergency Department Presentations due to Opioid Toxicity

  The researchers will track the number of presentations to the emergency department with a chief complaint of opioid toxicity.

  From patch application to post-operative day 21

• Emergency Department Presentations due to Uncontrolled Pain

  The investigators will track the number of emergency department presentations, with a chief complaint of uncontrolled post-operative pain.

  From patch application through post-operative day 21.

• Hospital Readmissions due to Uncontrolled Post-operative Pain

  The investigators will track the number of hospital readmissions due to uncontrolled post-operative pain.

  From patch application through post-operative day 21.

• Adverse Effects Related to Opioid Medication

  After surgery, patients will record whether they have symptoms of constipation, nausea, vomiting, drowsiness, or anything other symptoms potentially related to their opioid medication. The frequency and types of adverse effects will be recorded by the study researchers.

  Post-operative days 1-8, 21.

Secondary Outcomes (12)

• Morphine Milligram Equivalents of Full-Agonist Opioids Administered in Perioperative Setting

  Perioperative/Periprocedural

• Time from Surgery Completion to Discharge

  Perioperative/periprocedural

• Hospital Length of Stay

  From the completion of ankle fracture surgery to hospital discharge.

• Number of Breakthrough Pain Episodes while Inpatient

  Post-operative day 0 through hospital discharge

• Quality of Recovery after Anesthesia 15-Question Survey

  Post-operative day 7

Study Arms (2)

Buprenorphine Transdermal System

EXPERIMENTAL

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.

Drug: Buprenorphine Transdermal System

Placebo Patch

PLACEBO COMPARATOR

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.

Drug: Placebo Patch

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.

Buprenorphine Transdermal System

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.

Placebo Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jenna-Leigh Wilson: lead
• The Foundation for Barnes-Jewish Hospital: collaborator
• Washington University Institute of Clinical and Translational Sciences: collaborator

Study Sites (1)

Washington University in St. Louis/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Pain, Postoperative; Opioid-Related Disorders; Ankle Fractures

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Jenna Wilson, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah J Harrison, MD, MMSc

CONTACT

314-459-1140; nharrison@wustl.edu

Juanita Taylor, MPA, BS, RRT

CONTACT

314-454-7047; jrtaylor@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 29, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning at the time of publication and ending 36 months after publication.
• Access Criteria: Deidentified participant data will be shared with other investigators based on any reasonable request, as deemed appropriate by the study team. Requests may be submitted to Noah Harrison at nharrison@wustl.edu for review. Link to data will be provided at the time of request approval.

Locations

US (1)