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

RecruitingPhase 4Ages 18 Years - anyAllJenna-Leigh Wilson
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Buprenorphine Transdermal System
  • Placebo Patch
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Where

1 site
Washington University in St. Louis/Barnes Jewish Hospital
St Louis, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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