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

Study Overview
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Brief Summary
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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.

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

Conditions
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Shoulder Disease

Intervention / Treatment
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* Drug: Tranexamic acid injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 - Male or female aged 18 years old or more; 2- Patient requiring shoulder arthroscopy; 3 - Patient affiliated to a social security scheme; 4 - Patient informed on the study and who has signed the informed consent form. Exclusion Criteria: - Tranexamic acid contraindications (Hypersensitivity to the active substance or to any of the excipients, Acute venous or arterial thrombosis, Severe renal impairment, History of convulsions); - Pregnant or breastfeeding patient; - Patient under legal protection; - Patient taking part simultaneously to another clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional, prospective, national monocentric study, randomized in parallel groups, comparative versus placebo, double-blind (patient and investigating surgeon). Group 1: Surgery with intravenous injection of tranexamic acid Group 2: Surgery with intravenous injection of Placebo (0.9% sodium chloride)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery with intravenous injection of tranexamic acid<br>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. | Drug: Tranexamic acid injection<br>* 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.<br>|
| Placebo Comparator: Surgery with intravenous injection of Placebo (0.9% sodium chloride)<br>A 100 mL infusion bag of sodium chloride will be administered as a slow infusion over 10 minutes. | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no). | Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no). | At 24 hours post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of postoperative shoulder pain between the two groups | Shoulder pain is assessed through a Visual Analog Scale (0-100) performed 24 hours post-operative and 7 days after surgery (online assessment with the help of software) | At 24 hours and 7 days after surgery | 
| Evaluation of patient satisfaction between the two groups | Satisfaction will be assessed through an Evaluation of the Experience of General Anesthesia questionnaire. | The day after surgery | 
| Assessment of shoulder functionality between the two groups | The functionality of the shoulder will be evaluated by the Subjective Shoulder Value scale. Not normal shoulder that would scored 0% and normal shoulder that would scored 100%. | Before surgery and at the day 30 after surgery | 
| Assessment of shoulder functionality between the two groups | The functionality of the shoulder will be evaluated by the Constant Score. | Before surgery and at the day 30 after surgery | 
| Evaluation of the safety of the treatments under study between the two groups | Collection of adverse events throughout the duration of the study. | Continuously from surgery up to 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Pain, Arthroscopic shoulder surgery