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NCT Number: NCT06384456

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

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).

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Key information

Conditions

Distal Radius Fractures Acute Pain Arm Injuries Fractures, Bone Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Toronto Western Hospital

Toronto, Ontario, Canada

Location status: Recruiting

Location contact

Ryan Paul, MD

CONTACT

[email protected]

416-603-5641

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Topical tranexamic acid

Drug

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

Placebo

Drug

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

Primary outcomes

  1. acute post-op pain

    Time frame: 24 hours to 72 hours postoperatively

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

Secondary outcomes

  1. opioid use

    Time frame: 1, 2, and 6-week post-surgery

    Opioid use will be recorded on patients' medication diary

  2. persistent pain

    Time frame: 1, 2, and 6-week post-surgery

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

  3. unscheduled hand-related procedures

    Time frame: 1, 2, and 6-week post-surgery

    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

  4. Patient reported function

    Time frame: 1, 2, and 6-week post-surgery

    will be assessed using the disabilities of the arm, shoulder and hand questionnaire (DASH) score 0 to 100, with higher score indicating more disability.

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan Paul

CONTACT

[email protected]

416-603-5839

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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

Acronym: TRADR

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 25, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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