A Study on the Pain Control Effects of Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block and Axillary Nerve Block in Ar-throscopic Rotator Cuff Repair: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- visual analog pain scale (VAS)
研究概览
简要总结
This study is a prospective, randomized, double-blind trial comparing patients who underwent arthroscopic rotator cuff repair and received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75% ropivacaine) versus those who received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with placebo suprascapular and axillary nerve blocks (each with 10 ml of 0.9% saline).
The study will compare subjective pain scores (VAS score) and patient satisfaction preoperatively and at 1, 3, 6, 12, 18, 24, 36, and 48 hours postoperatively. Additionally, 5 ml of venous blood will be collected preoperatively and at 1, 6, 12, 24, and 48 hours postoperatively to analyze and compare serum levels of cortisol, IL-6, IL-8, IL-1β, substance P, serotonin, β-endorphin, and norepinephrine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
An independent nurse uses a random number generator and allocates paticipants into the two group. Participant, investigator, and outcome assessor are blinded of the allocation information.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a definite rotator cuff tear that needed repair seen on preoperative magnetic resonancce imaging (MRI)
- •acceptance of arthroscopic surgery including rotator cuff repair
- •age same as or more than 20 years
- •acceptance of preemptive regional block and PCA, and blood testing
排除标准
- •did not undergo arthroscopic rotator cuff repair
- •stopped PCA before 48 hours postoperatively because of associated side effects
- •a history of previous ipsilateral shoulder operation or fracture
- •a concomitant neurologic disorder around the shoulder
- •a failure of blood sampling including hemolysis, etc.
结局指标
主要结局
visual analog pain scale (VAS)
时间窗: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
0-10, 0: no pain, 10: very severe pain
次要结局
- Patient's satisfaction (SAT)(preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s))
- IL-6(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- Serotonin(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- plasma Cortisol(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- IL-8(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- IL-1β(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- Substance P(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- β -endorphin(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- norepinephrine(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
研究者
Jung-Taek Hwang
Professor
Chuncheon Sacred Heart Hospital