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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether applying a medication called topical tranexamic acid (TXA) directly to the surgical wound after surgery for wrist fractures can help reduce pain, decrease the need for painkillers, and improve wrist use during recovery. The trial will compare the results of patients who receive TXA with those who receive a placebo, which is a treatment that looks the same but has no active medication.

To participate in this study, you need to be at least 18 years old and scheduled for a specific type of surgery called open reduction internal fixation for a distal radius fracture. However, some people may not be eligible, including those who have certain medical conditions, are currently on specific medications, or have had previous surgeries on the same wrist. If you join the study, you can expect to receive either the TXA or placebo and will be monitored for your pain levels and how well you use your wrist after surgery. This trial is not yet recruiting participants, but it aims to improve pain management for patients undergoing this kind of surgery.

Gender

ALL

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).