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临床试验/NCT03212443
NCT03212443已完成不适用

Combined Suprascapular and Axillary Nerve Blocks for Sevoflurane Consumption and Postoperative Analgesia in Arthroscopic Shoulder Surgery

Diskapi Teaching and Research Hospital2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2017年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Postoperative VAS scores

研究概览

简要总结

Arthroscopic shoulder surgery is associated with severe pain postoperatively. Regional nerve block adding to general anesthesia might improve the quality of postoperative analgesia. The aim of the study is to compare the subacromial local anesthetic infiltration and the suprascapular-axillary nerve blocks combination for intraoperative sevoflurane consumption, postoperative analgesia and analgesic consumption.

详细描述

After informed consent and with ethics approval, 60 ASA 2-3 patients scheduled for elective arthroscopic shoulder surgery will be included in this study. Patient will be divided to two groups by using computer -generated list for randomization. In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure. In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia. In all patients after standard and BIS (Bi spectral index) monitorization general anesthesia will be induced with remifentanil (10mcg iv), propofol (2.5 mg/kg iv) and rocuronium (0.5mg/kg iv). After intubation, anesthesia will be maintained with 50% O2 and N2O mixture. Hemodynamic parameters, BIS values, end-tidal sevoflurane consumption will be recorded by blind investigator. Postoperative visual analog scale (VAS) values, postoperative analgesic consumption (Tramadol, patient controlled analgesia), complications will be recorded.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American society of anesthesia physical status (ASA) 1,2 patients
  • Elective arthroscopic shoulder surgery

排除标准

  • ASA 3,4 patients
  • Coagulation abnormality
  • Body mass index >30
  • Preexisting neurological deficit Local anesthetic allergy history Diabetes

研究组 & 干预措施

Group A

Sham Comparator

In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure

干预措施: Subacromial infiltration (Procedure)

Group B

Active Comparator

In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia

干预措施: Suprascapular nerve- axillary nerve block combination (Procedure)

结局指标

主要结局

Postoperative VAS scores

时间窗: Through postoperative period, an avarage of 30 minutes

Ranging from 0: no pain to 10: worst pain

次要结局

  • sevoflurane consumption(5th, 10th,20th,30th,40th,50th minutes after induction of anesthesia)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

derya özkan

Associated professor

Diskapi Teaching and Research Hospital

研究点 (2)

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