The Effect of Dexmedetomidine for Suprascapular Nerve Block With Axillary Nerve Block on Plasma Cortisol and Pain-related Cytokines After Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- visual analog scale of pain
研究概览
简要总结
Suprascapular nerve block (SSNB) is most commonly used for relieving postoperative pain of arthroscopic rotator cuff repair and it can be used in combination with axillary nerve block (ANB). Dexmedetomidine (DEX) is known as a type of alpha agonist which can elongate the duration of regional block. The aim of this study was to compare the results of dexmedetomidine combined with SSNB and ANB with SSNB and ANB alone on postoperative pain, satisfaction, and pain-related cytokines within the first 48 hours after arthroscopic rotator cuff repair.
Forty patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled in this single center, double-blinded randomized controlled trial study. Twenty patients were randomly allocated to group 1 and received ultrasound-guided SSNB and ANB using each mixture of 0.5 ml (50 μg) of DEX and 9.5 ml of 0.75% ropivacaine preemptively. The other 20 patients were allocated to group 2 and underwent ultrasound-guided SSNB and ANB alone using a mixture of 0.5 ml of normal saline and 9.5 ml of ropivacaine. The visual analog scale (VAS) for pain and patient satisfaction (SAT) scores were checked within 48 h postoperatively. The plasma interleukin (IL)-6, -8,-1β, cortisol, and serotonin levels were also measured within 48 h postoperatively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •defined rotator cuff tear on preoperative MRI, which indicated repair
- •acceptable arthroscopic surgery, including rotator cuff repair
- •patients >20 years old
- •acceptable routine regional blocks and patient-controlled analgesia (PCA)
排除标准
- •did not undergo arthroscopic rotator cuff repair
- •stopped PCA before 48 h postoperatively due to side effects
- •had a concomitant operation for a Bankart lesion
- •had a history of shoulder operation or fracture
- •had a concomitant neurological disorder around the shoulder
- •underwent conversion to open surgery from the arthroscopy
- •had contraindications for the routine regional blocks used in this study
- •had an known allergy or hypersensitivity against ropivacaine or dexmedetomidine, including other amino-amide local anesthetics or α2-adrenoceptor agonists.
研究组 & 干预措施
SSNB and ANB c DEX
We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for SSNB and ANB.
干预措施: Dexmedetomidine injection (Drug)
SSNB and ANB c saline
We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for SSNB and ANB.
干预措施: Saline injection (Drug)
结局指标
主要结局
visual analog scale of pain
时间窗: change from baseline VAS pain score at hour 48
The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain.
次要结局
- Plasma cortisol level(change from baseline plasma cortisol level at hour 48)
- patient's satisfaction(change from baseline patient's satisfaction score at hour 48)
- Plasma IL-6 level(change from baseline plasma IL-6 level at hour 48)
- Plasma serotonin level(change from baseline plasma serotonin level at hour 48)
- Plasma IL-8 level(change from baseline plasma IL-8 level at hour 48)
- Plasma IL-1β level(change from baseline plasma IL-1β level at hour 48)
研究者
Jung-Taek Hwang
Associate Professor
Chuncheon Sacred Heart Hospital