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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Topical TRanexamic Acid

    Drug

    10mL of 100mg/mL TXA will be administered into the surgical wound prior closure.

  • Placebo

    Drug

    10mL of 100mg/mL normal saline will be administered into the surgical wound prior closure.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Topical TRanexamic AcidExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

acute post-op pain

It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.

Time frame
24 hours to 72 hours postoperatively

Secondary outcomes

1

opioid use

Opioid use will be recorded on patients' medication diary

Time frame
1, 2, and 6-week post-surgery
2

persistent pain

It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.

Time frame
1, 2, and 6-week post-surgery
3

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

Time frame
1, 2, and 6-week post-surgery
4

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.

Time frame
1, 2, and 6-week post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.