About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Topical TRanexamic Acid
Drug10mL of 100mg/mL TXA will be administered into the surgical wound prior closure.
Placebo
Drug10mL of 100mg/mL normal saline will be administered into the surgical wound prior closure.
Treatment groups
Trial outcomes
Primary outcomes
acute post-op pain
It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.
Secondary outcomes
opioid use
Opioid use will be recorded on patients' medication diary
persistent pain
It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.
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
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.
Sponsors and contacts
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