RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-21
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06949826

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is 18 years of age or older
  2. * Patient is undergoing single stage ORIF of an ankle fracture
  3. * Patient is English-speaking
  1. * Patient is under 18 years of age
  2. * Patient's ankle fracture is treated with external fixation
  3. * Patient has a concomitant osseous or visceral injury
  4. * Patient has a history of opioid use disorder or a current diagnosis of opioid use disorder
  5. * Patient has a history of alcohol use disorder or a current diagnosis of alcohol use disorder
  6. * Patient was taking opioid medication or narcotic drugs prior to their injury
  7. * Patient has a current active malignancy
  8. * 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
  9. * Patient has an anaphylactic allergy to buprenorphine, hydrocodone, or oxycodone
  10. * Patient is not English-speaking
  11. * Patient is pregnant
  12. * Patient is unable to complete pain diary or communicate pain scores
  13. * Patient is incarcerated
  14. * Patient has a Gustilo-Anderson Type III open fracture

Contacts and Locations

Study Contact

Noah J Harrison, MD, MMSc
CONTACT
314-459-1140
nharrison@wustl.edu
Juanita Taylor, MPA, BS, RRT
CONTACT
314-454-7047
jrtaylor@wustl.edu

Principal Investigator

Jenna Wilson, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University in St. Louis/Barnes Jewish Hospital
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Jenna-Leigh Wilson

  • Jenna Wilson, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-21
Study Completion Date2027-06

Study Record Updates

Study Start Date2025-04-21
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

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