RecruitingPhase 4ACTRN12618001600235

Does the medication 'tranexamic acid' decrease pain and improve function in the short term after arthroscopic meniscectomy?


Sponsor

Prof Gary Hooper

Enrollment

40 participants

Start Date

Apr 20, 2018

Study Type

Interventional

Conditions

Summary

The aim of this pilot study is assess the efficacy of tranexamic acid in reducing post-operative pain, swelling and range of motion in patients undergoing arthroscopic meniscectomies. It is a blinded study in which participants are randomised to receive one intraoperative dose of either intravenous tranexamic acid or placebo (saline). Data collected is as follows: pain (0-10 scale), Lysholm knee score and Tegener activity score (to assess function), range of motion (measured by goniometer), suprapatellar and mid-calf circumferences (to assess swelling). Each of these data sets is collected pre-operatively (on the morning of surgery) and at three time points post-operatively (3, 14 and 30 days).


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

A meniscal tear is a common knee injury where the cartilage cushioning the knee joint is damaged. Arthroscopic meniscectomy — a minimally invasive keyhole surgery to trim away the damaged cartilage — is frequently performed to relieve pain and restore movement. However, after this surgery, pain, swelling, and stiffness can limit recovery in the first few weeks. Tranexamic acid is a medication that reduces bleeding and inflammation, and it has shown promise in reducing post-operative pain and swelling after other types of surgery. This pilot study tests whether a single intravenous dose of tranexamic acid given during arthroscopic meniscectomy reduces post-operative pain and swelling compared to placebo (saline). Participants are randomly assigned to receive either tranexamic acid or placebo during their surgery. Pain, knee function, range of motion, and swelling are measured before surgery and at three, fourteen, and thirty days afterwards. To be eligible you need to be having elective arthroscopic meniscectomy for a meniscal tear. People who have had previous reconstructive surgery on the same knee, known clotting disorders, kidney problems, or a known allergy to tranexamic acid are not eligible. This study involves no extra visits beyond the routine post-operative follow-ups.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Administration of tranexamic acid (one dose 1g in 10ml of 0.9% saline solution) or placebo (10ml 0.9% saline solution) intraoperatively. This is administered intravenously by the anaesthetist immediat

Administration of tranexamic acid (one dose 1g in 10ml of 0.9% saline solution) or placebo (10ml 0.9% saline solution) intraoperatively. This is administered intravenously by the anaesthetist immediately post-induction.


Locations(1)

Canterbury, New Zealand

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ACTRN12618001600235