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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Distal Radius Fractures
• Intervention / Treatment: Drug: Topical TRanexamic Acid; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ryan Paul; Phone Number: 416-603-5839; Email: jhanna.bermudez@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Toronto Western Hospital
      • Contact: Ryan Paul, MD; Phone Number: 416-603-5641; Email: ryan.paul2@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical TRanexamic Acid; 10mL of 100mg/mL TXA in addition to the standard care	Drug: Topical TRanexamic Acid; 10mL of 100mg/mL TXA will be administered into the surgical wound prior closure.
Placebo Comparator: Placebo; 10mL of 100mg/mL normal saline in addition to the standard care	Drug: Placebo; 10mL of 100mg/mL normal saline will be administered into the surgical wound prior closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid use	Opioid use will be recorded on patients' medication diary	1, 2, and 6-week post-surgery
persistent pain	It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.	1, 2, and 6-week post-surgery
unscheduled hand-related procedures	clinic/emergency unit visits or any issue or events related to the condition that might lead participant to visit the emergency room, be seen by a doctor, or undergo any intervention more frequently than the usual visits	1, 2, and 6-week post-surgery
Patient reported function	will be assessed using the disabilities of the arm, shoulder and hand questionnaire (DASH) score 0 to 100, with higher score indicating more disability.	1, 2, and 6-week post-surgery

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: acute pain; Placebo; Randomized Control Trial; Distal Radius Fractures; Topical tranexamic acid; Open Reduction and Internal FIxation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Fractures, Bone; Arm Injuries; Wrist Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Wrist Fractures; Acute Pain; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 23-5708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No