The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy on Total Blood Loss; a Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- serum hemoglobin exchange
研究概览
简要总结
Nerve blocks are used for pain and surgery after many operations today. It has been demonstrated by studies that the amount of postoperative bleeding decreases. On the other hand, surgical teams can use additional medications, such as Tranexamic acid, which have been proven by different studies that have reduced bleeding during and after arthroscopic surgery.
详细描述
The investigators aimed to investigate the effect of interscalene block application and tranexamic acid on bleeding in shoulder arthroscopy operation.
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
- Single (Outcomes Assessor)
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
- •Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- •underwent elective shoulder arthroscopy
- •Patients with consent to participate in the study
排除标准
- •history of arterial or venous thromboembolic disease
- •Bleeding diathesis disorder
- •Allergy to local anesthetics
- •cardiac stent placement
研究组 & 干预措施
Group I
interscalene block + General anesthesia
干预措施: interscalene block (Other)
Group I
interscalene block + General anesthesia
干预措施: general anesthesia (Other)
Group T
Tranexamic acid +General anesthesia
干预措施: tranexamic acid (Drug)
Group T
Tranexamic acid +General anesthesia
干预措施: general anesthesia (Other)
Group S
General anesthesia
干预措施: general anesthesia (Other)
结局指标
主要结局
serum hemoglobin exchange
时间窗: preoperative, postoperative 1st and 2nd day
change of serum hemoglobin before and after operation
次要结局
- postoperative bleeding amount(postoperative 24 hours)
- Visual Analog Scale(Postoperative 24 hours)
研究者
Korgün Ökmen
Principal Investigator ,Assoc. PhD. M.D.
Bursa Yüksek İhtisas Education and Research Hospital