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

A Single-institution, Parallel, Double-blinded, Randomized Study Assessing the Safety and Efficacy of Transdermal Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Opioid Use Disorder; Opioid Dependence; Ankle Fracture Surgery; Opioid Analgesia
• Intervention / Treatment: Drug: Buprenorphine Transdermal System; Drug: Placebo Patch

Detailed Description

Addictive full-agonist opioids, like oxycodone, remain a staple of post-operative analgesia after many types of surgery. However, perioperative exposure to opioid analgesics risks addiction in up to 7% of cases. Moreover, opioid overdoses kill over 80,000 in the United States (US) annually. Buprenorphine, a partial-agonist of the μ-opioid receptor and an antagonist of the κ-opioid receptor, may be able to safely function as a post-operative analgesic, reducing our reliance on full-agonist opioids post-operatively. Compared to full-agonist opioids, buprenorphine has a favorable safety profile. It has been hypothesized that buprenorphine's unique pharmacodynamics give it a lower addictive potential compared to full-agonist opioids. Moreover, it endows a ceiling on respiratory depression, has reduced dysphoric and psychotomimetic effects, and does not result in immunosuppression at therapeutic analgesic doses. International studies have suggested that transdermal buprenorphine is noninferior to tramadol, transdermal fentanyl, and oral celecoxib in the management of acute post-operative pain in opioid-naïve patients following orthopaedic surgery. However, the efficacy of buprenorphine for postoperative analgesia has never been studied in the United States, whose population has different beliefs and expectations surrounding pain control when compared to international populations. The major goal of this project is to determine the safety and efficacy of transdermal buprenorphine for postoperative analgesia, as a first step toward exploring the ability of buprenorphine to mitigate the incidence of opioid dependence in the postoperative setting.

This study will assess whether buprenorphine can reduce the use of full-agonist opioids following ankle fracture surgery. Approximately one in five opioid-naïve patients undergoing ankle fracture surgery continue to use opioids 3 to 6 months out from surgery, suggesting that this population is relatively susceptible to developing post-operative opioid dependence. The investigators will divide patients into two groups. One group will be treated with a 7-day transdermal buprenorphine patch. The other will be treated with a placebo patch. Both groups will otherwise receive a post-operative pain management regimen that is in accordance with the standard of care. The investigators hypothesize that participants treated with the buprenorphine patch will experience improved analgesia with the use fewer full-agonist opioids following ankle fracture surgery than those treated with the placebo patch. This hypothesis will be tested with the following aims.

Specific Aim 1: To measure the analgesic effect of buprenorphine on post-operative analgesia. In this Aim, the investigators will test the hypothesis that use of buprenorphine patches will reduce the average pain scores and consumption of full-agonist opioids after ankle fracture surgery. In sub-Aim 1.1, the investigators will quantify postoperative pain by monitoring participants' visual analog scale pain scores and full-agonist opioid consumption over the first post-operative week. In sub-Aim 1.2, the investigators will track the number of episodes of breakthrough pain in the hospital, the number of calls to the clinic with a chief complaint of uncontrolled pain, and the number of presentations to an emergency department for uncontrolled surgery-related pain.

Specific Aim 2: To examine the safety of buprenorphine as a post-operative analgesic following ankle fracture surgery. In this Aim, the investigators will test the hypothesis that participants treated with buprenorphine patches will experience fewer adverse events related to opioid exposure compared to those treated with placebo patches. The investigators will monitor for adverse effects of buprenorphine and full-agonist opioids, including respiratory depression, constipation, nausea, and vomiting. The investigators will track the number of presentations to an emergency department with a diagnosis of opioid toxicity. For pilot data, the investigators will also monitor use of opioids for analgesia at the 3-month postoperative time point as a secondary outcome.

This study assesses whether buprenorphine safely reduces full-agonist opioid use after orthopaedic surgery. Completion of the Aims of this study will permit future studies assessing whether buprenorphine comprises a less-addictive alternative for postoperative analgesia compared to full-agonist opioids. Annually, there are 40-50 million major surgeries performed in the US. As 6-7% of opioid-naïve patients develop long-term opioid use after major surgery, exploring avenues to decrease the impact of post-operative analgesia on the opioid epidemic is critical.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Noah J Harrison, MD, MMSc; Phone Number: 314-459-1140; Email: nharrison@wustl.edu
• Study Contact Backup: Name: Juanita Taylor, MPA, BS, RRT; Phone Number: 314-454-7047; Email: jrtaylor@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University in St. Louis/Barnes Jewish Hospital
      • Contact: Noah J Harrison, MD, MMSc; Phone Number: 314-459-1140; Email: nharrison@wustl.edu
      • Contact: Juanita R Tylor, MPA, BS, RRT; Phone Number: 314-454-7047; Email: jrtaylor@wustl.edu
      • Principal Investigator: Jenna L Wilson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Morphine Milligram Equivalents of Full-Agonist Opioids Administered in Perioperative Setting	Review of the medication administration record will be performed to calculate the morphine milligram equivalents of opioid medication administered during ankle fracture surgery and in the post-operative recovery unit.	Perioperative/Periprocedural
Time from Surgery Completion to Discharge	For patients undergoing outpatient surgery, review of the electronic medical record will be performed to determine the time from surgery completion to discharge.	Perioperative/periprocedural
Hospital Length of Stay	For patients being admitted to the hospital to recover after ankle fracture surgery, review of the electronic medical record will be performed to determine the average hospital length of stay for each group.	From the completion of ankle fracture surgery to hospital discharge.
Number of Breakthrough Pain Episodes while Inpatient	For patients admitted after surgery, the number of breakthrough pain episodes while inpatient will be determined. A breakthrough pain episode will be defined as a sudden, severe, brief pain occurring in the setting go f adequately controlled mild-moderate background pain. It will be denoted by the administration of a medication in the inpatient setting with an indication of "for breakthrough pain."	Post-operative day 0 through hospital discharge
Quality of Recovery after Anesthesia 15-Question Survey	Patients will complete the quality of recovery after anesthesia 15-question survey. Scores range from 0 to 150. A score of 0 represents a poor recovery after anesthesia. A score of 150 represents an excellent recover after anesthesia.	Post-operative day 7
Telephone Calls and MyChart Messages to Clinic or Call Center with a Chief Complaint of Uncontrolled Pain	Review of the electronic medical record will be performed to record the average number of telephone calls and MyChart messages to the orthopaedic surgery clinic or call center with a chief complaint of uncontrolled pain.	Post-operative days 0-21.
Opioid Medication Prescriptions - Number and Total Morphine Milligram Equivalents Prescribed	The researchers will review the electronic medical record to record the number of opioid medication prescriptions requested and filled by the patient.	From the time of injury through post-operative day 90.
Drug Liking and Economic Choice Survey	Patients will be asked by questionnaire how much they liked their buprenorphine vs placebo patch and oral narcotic prescriptions, as well as how much they would pay for their buprenorphine vs placebo patch and oral full-agonist opioid prescription.	Post-operative days 7, 21, 90
Patient Satisfaction with Post-operative Pain Control	Patient satisfaction with their post-operative pain control will be recorded by questionnaire in the form of a Likert scale.	Post-operative days 7, 21
Rate of Persistent Opioid Use	Approximately three months after surgery, patients will record whether they are continuing to take opioids/narcotics for pain related to their ankle fracture surgery.	Post-operative day 90
Prescription Pain Medication Misuse Short Form 7a Scores	Patients will complete the PROMIS Prescription Pain Medication Misuse Short Form 7a. Scores will be tabulated from 0 to 35. A score of 35 represents a high level of pain medication misuse. A score of 0 represents a low level of pain medication misuse.	Post-operative day 90
Post-operative Complication Rate	The researchers will review the electronic medical record to the rate and type of post-operative complications after ankle fracture surgery.	Post-operative days 0-90

Collaborators and Investigators

• Sponsor: Jenna-Leigh Wilson
• Collaborators: The Foundation for Barnes-Jewish Hospital; Washington University Institute of Clinical and Translational Sciences
• Investigators: Principal Investigator: Jenna Wilson, MD, Washington University School of Medicine

Publications and helpful links

General Publications

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• Pergolizzi JV Jr, Magnusson P, LeQuang JA, Breve F, Mitchell K, Chopra M, Varrassi G. Transdermal Buprenorphine for Acute Pain in the Clinical Setting: A Narrative Review. J Pain Res. 2021 Mar 31;14:871-879. doi: 10.2147/JPR.S280572. eCollection 2021.
• Desai SN, Badiger SV, Tokur SB, Naik PA. Safety and efficacy of transdermal buprenorphine versus oral tramadol for the treatment of post-operative pain following surgery for fracture neck of femur: A prospective, randomised clinical study. Indian J Anaesth. 2017 Mar;61(3):225-229. doi: 10.4103/ija.IJA_208_16.
• Kim HJ, Ahn HS, Nam Y, Chang BS, Lee CK, Yeom JS. Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial. Eur Spine J. 2017 Nov;26(11):2961-2968. doi: 10.1007/s00586-017-5213-5. Epub 2017 Jul 20.
• Londhe S, Patwardhan M, Shah R, Oak M. Efficacy and Safety of Buprenorphine Transdermal Patch for Immediate Postoperative Analgesia After Total Knee Arthroplasty Surgery. J Arthroplasty. 2020 Jun;35(6S):S178-S181. doi: 10.1016/j.arth.2020.02.015. Epub 2020 Feb 13.
• Londhe SB, Patwardhan M, Shah RV, Oak M, Shah A, Antao N, Khot R. Comparison of Efficacy and Safety of Transdermal Buprenorphine Patch and Conventional Analgesics in Intra-capsular Femur Neck Fracture Post Hemiarthroplasty. Indian J Orthop. 2022 Jun 25;56(8):1363-1369. doi: 10.1007/s43465-022-00668-7. eCollection 2022 Aug.
• Niyogi S, Bhunia P, Nayak J, Santra S, Acharjee A, Chakraborty I. Efficacy of transdermal buprenorphine patch on post-operative pain relief after elective spinal instrumentation surgery. Indian J Anaesth. 2017 Nov;61(11):923-929. doi: 10.4103/ija.IJA_118_17.
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• Khandelwal H, Negi A, Govil N, Singh A, Parag K, Bhardwaj BB. Comparative evaluation of analgesic efficacy of buprenorphine transdermal patch and fentanyl patch in management of postoperative pain after arthroscopic lower limb surgery: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):272-278. doi: 10.4103/joacp.JOACP_405_20. Epub 2021 Jul 15.
• Lee JH, Kim JH, Kim JH, Kim HS, Min WK, Park YS, Lee KY, Lee JH. Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery. Pain Res Manag. 2017;2017:2071494. doi: 10.1155/2017/2071494. Epub 2017 Sep 13.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative pain; Buprenorphine; Opioid use disorder; Ankle fracture; Opioid Addiction; Transdermal buprenorphine; Ankle fracture surgery; Opioid-naive patient; ORIF Ankle Fracture; Buprenorphine for postoperative pain
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Leg Injuries; Substance-Related Disorders; Chemically-Induced Disorders; Fractures, Bone; Ankle Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Opioid-Related Disorders; Ankle Fractures; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 202406162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After deidentification, all individual participant data may be shared.
• IPD Sharing Time Frame: Beginning at the time of publication and ending 36 months after publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No