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

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

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.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06384456 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Toronto, Ontario

• Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Ryan Paul

Conditions Distal Radius Fractures; acute pain; Topical tranexamic acid; Open Reduction and Internal FIxation; Placebo; Randomized Control Trial