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

Distal Radius Fractures Clinical Trial

— TRADR  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384456
• Other study ID #: 23-5708
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2024
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: University Health Network, Toronto
• Contact: Ryan Paul
• Phone: 416-603-5839
• Email: jhanna.bermudez[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Pain, Postoperative
• Radius Fractures
• Wrist Fractures

Intervention

Drug:
• Topical TRanexamic Acid
10mL of 100mg/mL TXA will be administered into the surgical wound prior closure.
• Placebo
10mL of 100mg/mL normal saline will be administered into the surgical wound prior closure.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	opioid use	Opioid use will be recorded on patients' medication diary	1, 2, and 6-week post-surgery
Secondary	persistent pain	It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.	1, 2, and 6-week post-surgery
Secondary	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
Secondary	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