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New treatment option for Pain, Postoperative
Official title Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery
ClinicalTrials.gov ID: NCT06949826
What this study is testing
What is Buprenorphine Transdermal System?
Buprenorphine Transdermal System is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pain, postoperative.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient is 18 years of age or older
- Patient is undergoing single stage ORIF of an ankle fracture
- Patient is English-speaking
You likely can't join 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
See the full eligibility criteria
- Patient is 18 years of age or older
- Patient is undergoing single stage ORIF of an ankle fracture
- Patient is English-speaking
- 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
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.