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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
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.
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.
Polyclinique Jean Villar
Bruges, France, France
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).
Time frame: At 24 hours post-operative
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)
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: Continuously from surgery up to 30 days after surgery
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