Clinical trial

The Effect of Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following Distal Radius Fracture Fixation: a Randomized Controlled Trial - The TRADR Study

Name

23-5708

Description

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).

Trial arms

Trial start

2024-08-01

Estimated PCD

2026-06-01

Trial end

2026-09-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Topical TRanexamic Acid

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

Arms:

Topical TRanexamic Acid

Placebo

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

Arms:

Placebo

Size

Primary endpoint

acute post-op pain

24 hours to 72 hours postoperatively

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).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2024-04-26

1 organization

1 product

1 drug

1 indication

Organization

University Health Network

Product

Topical Tranexamic Acid

Indication

Wrist Fractures

Drug

Varlilumab