Rate and Risk Factors Associated With Prolonged Opioid Use After Surgery: A Systematic Review and Meta-analysis.
Oluwadolapo D Lawal, Justin Gold, Amala Murthy...
https://pubmed.ncbi.nlm.nih.gov/32584407Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06949826
Safety and Efficacy of Transdermal Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery
Led by Jenna-Leigh Wilson · Updated on 2026-04-06
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
J
Jenna-Leigh Wilson
Lead Sponsor
T
The Foundation for Barnes-Jewish Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of buprenorphine, a partial opioid, to control pain after ankle fracture surgery in patients who have not previously taken opioids. The study aims to see if buprenorphine can reduce the use and addiction risk of full-agonist opioids like oxycodone and hydrocodone, which are commonly used but highly addictive. This pilot study is an important step toward safer post-operative pain management given the high rate of opioid dependence after surgery and the opioid epidemic in the United States. Participants will be randomly assigned to one of two groups. One group will receive a 7-day transdermal buprenorphine patch applied before surgery, while the other group will receive a placebo patch that looks the same but contains no drug. Both groups will otherwise follow standard pain management care after ankle fracture surgery. The study will monitor how much full-agonist opioid each participant uses, their reported pain levels, and side effects during the first week after surgery. Throughout the study, investigators will collect detailed information including pain scores, opioid consumption, episodes of breakthrough pain, and calls or messages to the clinic about uncontrolled pain. They will also monitor adverse effects related to opioid use, hospital readmissions, emergency visits, and opioid toxicity up to three months after surgery. The main outcome is the amount of full-agonist opioid used in the first week post-surgery. This thorough monitoring will help assess the safety and effectiveness of buprenorphine for post-operative pain management and its potential to reduce opioid dependence.
CONDITIONS
Brief Title
Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older
- Patient is undergoing single stage ORIF of an ankle fracture
- Patient is English-speaking
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 7 days
Participants receive either a transdermal buprenorphine patch or a placebo patch applied in the pre-operative holding area. Both groups follow the standard post-operative pain management regimen after ankle fracture surgery.
1 pre-operative visit (in-person) and daily patch use for 7 days
Follow-up
Duration - Up to 3 months after surgery
Participants are monitored for pain levels, opioid use, adverse effects, and recovery through approximately 3 months after surgery.
Visits and assessments approximately on post-operative days 7, 21, and 90
Trial Site Locations
Total: 1 location
1
Washington University in St. Louis/Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
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Research Team
N
Noah J Harrison, MD, MMSc
J
Juanita Taylor, MPA, BS, RRT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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D R Jasinski, J S Pevnick, J D Griffith
https://pubmed.ncbi.nlm.nih.gov/215096The Abuse Potential of Prescription Opioids in Humans-Closing in on the First Century of Research.
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S L Walsh, K L Preston, M L Stitzer...
https://pubmed.ncbi.nlm.nih.gov/8181201Clinical update on the pharmacology, efficacy and safety of transdermal buprenorphine.
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Joseph V Pergolizzi, Peter Magnusson, Jo Ann LeQuang...
https://pubmed.ncbi.nlm.nih.gov/33833565Safety 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.
Sameer N Desai, Santhoshi V Badiger, Shreesha B Tokur...
https://pubmed.ncbi.nlm.nih.gov/28405035Comparison between Transdermal Buprenorphine and Transdermal Fentanyl for Postoperative Pain Relief after Major Abdominal Surgeries.
Zia Arshad, Ravi Prakash, Shefali Gautam...
https://pubmed.ncbi.nlm.nih.gov/26816973Comparative 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.
Ho-Joong Kim, Hyo Sae Ahn, Yunjin Nam...
https://pubmed.ncbi.nlm.nih.gov/28730328