Effect of Ultrasound-guided Suprascapular Nerve Block and Axillary Nerve Block in Relieving Postoperative Pain After Arthroscopic Rotator Cuff Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 3
- 主要终点
- visual analog pain scale (VAS)
研究概览
简要总结
The goal of this clinical trial is to verify the effect of suprascapular nerve block and axillary nerve block in relieving postoperative pain after arthroscopic rotator cuff repair.
Are there differences in visual analog pain scale and patient's satisfaction? Are there differences in mean plasma pain related cytokines? The participants will undergo preemptive ultrasound guided suprascapular nerve block and axillary nerve block using each 0.75% ropivacaine 10mL or each 0.9% saline 10mL.
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.
研究组 & 干预措施
Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using ropivacaine
Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using each 0.75% ropivacaine 10mL when arthroscopic rotator cuff repair Patient Controlled Analgesia (PCA) at a low fixed dose: fentanyl-loading dose: 0.4㎍/kg, continuous dose: 0.2㎍/kg/h, nefopam-loading dose: 0.04mg/kg, continuous dose: 0.02mg/kg/h
干预措施: Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block (Procedure)
Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using saline
Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using each 0.9% saline 10mL when arthroscopic rotator cuff repair Patient Controlled Analgesia (PCA) at a low fixed dose: fentanyl-loading dose: 0.4㎍/kg, continuous dose: 0.2㎍/kg/h, nefopam-loading dose: 0.04mg/kg, continuous dose: 0.02mg/kg/h
干预措施: Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block (Procedure)
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
- Substance P(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- β -endorphin(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- Patient's satisfaction (SAT)(preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s))
- plasma Cortisol(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- IL-1β(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- Serotonin(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- norepinephrine(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- IL-6(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
- IL-8(preoperative, postoperative 1, 6, 12, 24, 48 hour(s))
研究者
Jung-Taek Hwang
Professor
Chuncheon Sacred Heart Hospital