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Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation

RecruitingPhase 4Ages 18 Years - anyAllUniversity Health Network, Toronto
NCT06384456 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to find out whether the use of topical tranexamic acid (TXA) into the surgical wound will result in less post-operative pain, less pain killer use, and better post-operative use of the wrist in people undergoing surgery for a wrist fracture compared to not using topical TXA (placebo).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients undergoing open reduction internal fixation (Volar approach) for operative management of a distal radius fracture; * Aged 18 or older; * Provision of informed consent; * Cognitive ability and English-language skills required to complete outcome measures. Exclusion Criteria: * Revision surgery or any additional operative management of ipsilateral wrist injury * Distal radius fracture treated with a dorsal approach * Known history of lymphedema or lymph node dissection in the operative extremity * Known chronic pain conditions, fibromyalgia, or polymyalgia rheumatic * Current user of opioids and/or on chronic opioids use * Known allergic reaction to TXA * Anticoagulant use not stopped in time for surgery as per thrombosis Canada guidelines (i.e. warfarin, acetylsalicylic acid, direct oral anticoagulants, etc.) * Previous thrombotic stroke or thromboembolic disorders (i.e. known previous DVT, PE, or clotting disorders) * Current pregnancy or breastfeeding * Previous neurologic injury causing paralysis of affected shoulder/arm * Severe cardio-respiratory disease (i.e. ASA Grade IV or higher).
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What it tests

  • Topical TRanexamic Acid
  • Placebo
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Where

1 site
Toronto Western Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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