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

Phase 4

Not yet recruiting

• Conditions: Distal Radius Fractures
• Interventions: Drug: Topical TRanexamic Acid; Drug: Placebo

• Registration Number: NCT06384456
• Lead Sponsor: University Health Network, Toronto

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).

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-25
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Study Start: 2024-08
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical TRanexamic Acid	Topical TRanexamic Acid	10mL of 100mg/mL TXA in addition to the standard care
Placebo	Placebo	10mL of 100mg/mL normal saline in addition to the standard care

Primary Outcome Measures

Name	Time	Method
acute post-op pain	24 hours to 72 hours postoperatively	It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.

Secondary Outcome Measures

Name	Time	Method
persistent pain	1, 2, and 6-week post-surgery	It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.
opioid use	1, 2, and 6-week post-surgery	Opioid use will be recorded on patients' medication diary
Patient reported function	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.
unscheduled hand-related procedures	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

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada