The Effect of Sono-Guided Interscalene Brachial Plexus Block Combined With Arthroscopy-Guided Suprascapular Nerve Block in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- Visual Analog Scale (VAS) Pain Score
研究概览
简要总结
The investigators compared the results of sono-guided interscalene brachial plexus block (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB alone within the first 48 h after arthroscopic rotator cuff repair.
详细描述
Forty-eight patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled. The 24 patients randomly allocated to group 1 received ISB and SSNB; the remaining 24 patients in group 2 underwent ISB alone. VAS pain score, patient's satisfaction (SAT) were checked postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours. VAS pain score was selected from 0 to 10 was no pain and 10 was severe pain that the patient had ever experienced. SAT was also selected from 0 to 10 was unsatisfactory and 10 was very satisfactory. Rebound of postoperative pain was confirmed if there had been an increase of VAS pain score after postoperative 1 hour.
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)
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
- •definite rotator cuff tear on preoperative MRI, which needed repair;
- •acceptance of arthroscopic surgery including rotator cuff repair;
- •> 20 years old; and
- •acceptance of routine regional blocks and patient-controlled analgesia.
排除标准
- •did not want arthroscopic rotator cuff repair;
- •stopped PCA before 48 h postoperatively due to side effects;
- •history of shoulder operation or fracture;
- •concomitant neurological disorder around the shoulder;
- •conversion to open surgery from the arthroscopy; and
- •contraindication to the routine regional blocks in this study
研究组 & 干预措施
ISB with SSNB
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.
干预措施: Ultrasound-guided ISB (Device)
ISB with SSNB
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.
干预措施: Arthroscopy-guided SSNB (Device)
ISB with SSNB
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.
干预措施: Placebo (Drug)
ISB with SSNB
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.
干预措施: Ropivacaine (Drug)
ISB alone
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.
干预措施: Ultrasound-guided ISB (Device)
ISB alone
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.
干预措施: Placebo (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) Pain Score
时间窗: 1, 3, 6, 12, 18, 24, 36, 48h
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
- Patient Satisfaction (SAT) Score(1, 3, 6, 12, 18, 24, 36, 48h)
研究者
Jung-Taek Hwang
Assistant Professor
Chuncheon Sacred Heart Hospital