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

University Health Network, Toronto

Status and phase: Begins enrollment in 2 months; Phase 4

Conditions: Distal Radius Fractures

Treatments: Drug: Placebo; Drug: Topical TRanexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06384456

23-5708

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Topical TRanexamic Acid

Experimental group

Description:

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

Treatment:

Drug: Topical TRanexamic Acid

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo