Distal Radius Fractures
Conditions
Keywords
Distal Radius Fractures, acute pain, Topical tranexamic acid, Open Reduction and Internal FIxation, Placebo, Randomized Control Trial
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).
Interventions
10mL of 100mg/mL TXA will be administered into the surgical wound prior closure.
DRUGPlacebo
10mL of 100mg/mL normal saline will be administered into the surgical wound prior closure.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| opioid use | 1, 2, and 6-week post-surgery | Opioid use will be recorded on patients' medication diary |
| persistent pain | 1, 2, and 6-week post-surgery | It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain. |
| 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 |
| 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. |
Countries
Canada
Contacts
Primary ContactRyan Paul
Outcome results
None listed