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

NCT06384456 | Recruiting Phase 4

• 1 other identifier: 23-5708
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Distal Radius Fractures

Keywords

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

Outcome Measures

Primary Outcomes (1)

• acute post-op pain

  It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.

  24 hours to 72 hours postoperatively

Secondary Outcomes (4)

• opioid use

  1, 2, and 6-week post-surgery

• persistent pain

  1, 2, and 6-week post-surgery

• unscheduled hand-related procedures

  1, 2, and 6-week post-surgery

• Patient reported function

  1, 2, and 6-week post-surgery

Study Arms (2)

Topical TRanexamic Acid

EXPERIMENTAL

10mL of 100mg/mL TXA in addition to the standard care

Drug: Topical TRanexamic Acid

Placebo

PLACEBO COMPARATOR

10mL of 100mg/mL normal saline in addition to the standard care

Drug: Placebo

Interventions

Topical TRanexamic Acid DRUG

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

Topical TRanexamic Acid

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, Canada

RECRUITING

Related Publications (1)

• Lameire DL, Noori A, Abbas A, Persitz J, Baltzer H, Collett E, Veillette C, Chan A, Paul R. The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation: protocol for a randomised controlled trial at a quaternary care hand surgery centre - The TRADR study. BMJ Open. 2025 May 21;15(5):e095684. doi: 10.1136/bmjopen-2024-095684.

  PMID: 40398932 DERIVED

MeSH Terms

Conditions

Wrist Fractures; Acute Pain

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Ryan Paul

CONTACT

416-603-5839; jhanna.bermudez@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: August 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CA (1)