Benefits on Post-operative Pain of Intravenous, Intraoperative, Tranexamic Acid Injection During Arthroscopic Shoulder Surgery.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The study will be conducted in a double-blind setting. The patient and the investigating surgeon will be blinded. The injection of the product will be performed by the anesthetist that will be aware of the injected product (tranexamic acid or sodium chloride).
入排标准
- 年龄范围
- 18 Years 至 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •- 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.
研究组 & 干预措施
Surgery with intravenous injection of tranexamic acid
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.
干预措施: Tranexamic acid injection (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).
时间窗: At 24 hours post-operative
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).
Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).
次要结局
- Evaluation of postoperative shoulder pain between the two groups(At 24 hours and 7 days after surgery)
- Evaluation of patient satisfaction between the two groups(The day after surgery)
- Assessment of shoulder functionality between the two groups(Before surgery and at the day 30 after surgery)
- Evaluation of the safety of the treatments under study between the two groups(Continuously from surgery up to 30 days after surgery)
- 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)
- Satisfaction will be assessed through an Evaluation of the Experience of General Anesthesia questionnaire.
- The functionality of the shoulder will be evaluated at 30 days by the Subjective Shoulder Value scale and and Constant Score.
- Collection of adverse events throughout the duration of the study.
研究者
Hugues DEMEZON
Scientific
Aquitaine Sante