RecruitingPhase 4NCT06384456

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

The Effect of Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following Distal Radius Fracture Fixation: a Randomized Controlled Trial - The TRADR Study


Sponsor

University Health Network, Toronto

Enrollment

90 participants

Start Date

Aug 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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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Interventions

DRUGTopical TRanexamic Acid

10mL of 100mg/mL TXA will be administered into the surgical wound prior closure.

DRUGPlacebo

10mL of 100mg/mL normal saline will be administered into the surgical wound prior closure.


Locations(1)

Toronto Western Hospital

Toronto, Ontario, Canada

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NCT06384456


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