Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical TRanexamic Acid, Placebo.
- Who it may be relevant to
- Registry conditions: Distal Radius Fractures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Drug Topical TRanexamic Acid
10mL of 100mg/mL TXA will be administered into the surgical wound prior closure. - Drug Placebo
10mL of 100mg/mL normal saline will be administered into the surgical wound prior closure.
Primary outcome measures
- acute post-op pain [Time frame: 24 hours to 72 hours postoperatively]
Secondary outcome measures (4)
- opioid use [Time frame: 1, 2, and 6-week post-surgery]
- persistent pain [Time frame: 1, 2, and 6-week post-surgery]
- unscheduled hand-related procedures [Time frame: 1, 2, and 6-week post-surgery]
- Patient reported function [Time frame: 1, 2, and 6-week post-surgery]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Toronto Western Hospital — Toronto
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. PMID 40398932
Identifiers
NCT: NCT06384456 · 23-5708