Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Topical tranexamic acid versus placebo to reduce acute pain after volar fixation of distal radius fractures

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

Run by University Health Network, Toronto · NCT06384456 · Data updated 2026-11-12

This will try placing topical tranexamic acid into the surgical wound to see if it reduces post-operative pain and opioid use for adults having volar open reduction and internal fixation of a distal radius fracture.

More Distal Radius Fractures trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment90 (estimated)
SponsorUniversity Health Network, Toronto
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedAugust 13, 2025
Main results expectedDecember 2026
Study endsDecember 2027
Registry record updatedMay 4, 2026
Trial IDNCT06384456 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) undergoing volar approach open reduction and internal fixation for a distal radius fracture who can provide informed consent, complete outcome measures in English, are not on chronic opioids, and have no contraindication to TXA are ideal candidates.

Probably not a fit

Patients treated with a dorsal approach or revision surgery, those with chronic pain or chronic opioid use, people with prior thromboembolic events, or anyone allergic to TXA are unlikely to be eligible or to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center Phase 4 interventional trial compares topical tranexamic acid applied into the surgical wound to a placebo in adults undergoing volar open reduction and internal fixation for distal radius fractures. Participants receive either topical TXA or placebo at the time of surgery, and postoperative outcomes including pain scores, opioid consumption, and wrist function are collected. Key exclusions include chronic pain disorders, current chronic opioid use, thromboembolic history, pregnancy or breastfeeding, and known allergy to TXA. The trial is conducted at Toronto Western Hospital using standardized perioperative care to limit confounding.

Why it matters

Potential benefit: If effective, topical TXA could reduce acute postoperative pain, decrease opioid requirements, and support earlier functional use of the wrist after fixation.

How similar studies have gone: Topical TXA has shown benefit in reducing bleeding and sometimes opioid use in other orthopedic procedures, but data specifically showing pain reduction after wrist ORIF are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

  • Toronto Western Hospital
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.