RecruitingPhase 3NCT05302986

Effect on Post-operative Pain of Tranexamic Acid Injection During Shoulder Surgery

Benefits on Post-operative Pain of Intravenous, Intraoperative, Tranexamic Acid Injection During Arthroscopic Shoulder Surgery.


Sponsor

Elsan

Enrollment

220 participants

Start Date

Feb 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Arthroscopic shoulder surgery is a commonly performed minimally invasive surgery in which a camera (an arthroscope) is inserted inside the shoulder joint. This surgery is responsible for moderate to severe pain. It may require the use of opioid analgesics in the acute phase. One of the components of this pain may be the postoperative hematoma. Pain is one of the main causes of patient satisfaction failure after shoulder surgery. Finding ways to reduce this pain is a primary principle in the management of this surgery. Until now, this management requires the frequent use of morphine. However, this use of morphine may conduct to adverse effects (nausea/vomiting, constipation, malaise, sweating), and even public health problems such as addiction. It is therefore interesting to look for ways to increase the patient's analgesia by other means, which will thus increase patient satisfaction and make his management more fluid. The effect on pain of hematoma reduction is rarely described in the scientific literature. The hypothesis of this study is that the intraoperative administration of intravenous (IV) tranexamic acid can reduce the hematoma and thus decrease postoperative pain.The aim of this study is to demonstrate that the use of IV tranexamic acid intraoperatively, compared to a placebo (sodium chloride 0.9%), reduces postoperative pain after arthroscopic shoulder surgery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether injecting tranexamic acid (a drug that reduces bleeding) during shoulder arthroscopy (a minimally invasive shoulder procedure) reduces post-operative pain. It may offer a simple way to improve pain management after common shoulder surgeries. You may be eligible if... - You are 18 or older - You need shoulder arthroscopy surgery - You are covered by a social security plan - You have provided written informed consent You may NOT be eligible if... - You have a contraindication to tranexamic acid (e.g., allergy, active blood clot, severe kidney problems, or history of seizures) - You are pregnant or breastfeeding - You are under legal protection - You are already enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

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

DRUGTranexamic acid injection

The dose will be 0.1 mg / kg (= 10 mg/kg) and diluted in a 100 mL infusion bag of sodium chloride. The product will have to be administered as a slow infusion over 10 minutes during the shoulder surgery.

DRUGPlacebo

Surgery with intravenous injection of Placebo (0.9% sodium chloride). A 100 mL infusion bag of sodium chloride will be administered as a slow infusion over 10 minutes during shoulder surgery.


Locations(1)

Polyclinique Jean Villar

Bruges, France, France

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NCT05302986


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