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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Distal Radius Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Topical TRanexamic Acid

10mL of 100mg/mL TXA in addition to the standard care

Group Type EXPERIMENTAL

Topical TRanexamic Acid

Intervention Type DRUG

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

Placebo

10mL of 100mg/mL normal saline in addition to the standard care

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Topical TRanexamic Acid

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No