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临床试验/NCT04236323
NCT04236323已完成不适用

The Effect of Remifentanil on Rebound Pain in Patients Receiving General Anesthesia for Shoulder Arthroplasty After Brachial Plexus Block for Postoperative Pain Control

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年2月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Total infused dose of patient controlled analgesia(PCA) drug during 24 hours

研究概览

简要总结

The investigators will evaluate the influence of intraoperative remifentanil infusion on the postoperative hyperalgesia in patients receiving rotator cuff repair after brachial plexus block for postoperative analgesia.

详细描述

The study will include 68 patients undergoing rotator cuff repair. All patients will receive brachial plexus block for postoperative analgesia, followed by general anesthesia. In the experimental group, remifentanil infusion will not be used intraoperatively, and in the control group, remifentanil will be infused. After surgery, both groups will be given the same postoperative pain management using patient controlled analgesia(PCA), and pain patterns will be assessed using the Numerical rating scale (NRS) at 4 hour intervals for 24 hours. The primary end point of this study is the total dose of PCA medication over 24 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA class I,II,III
  • Patients undergoing arthroscopic rotator cuff repair surgery under general anesthesia after interscalen brachial plexus block for post operative analgesia
  • Age ranges from 20 to 70

排除标准

  • Patients who didn't agree to study
  • Patients can't control PCA(Patient-Controlled-Analgesia) independently
  • Patients who have conciousness disorder or can't express their pain level by NRS(Numeric Rating Scale) system
  • Patients who have severe respiratory disease or hepatic failure
  • Patinets who have known neuropathy or coagulopathy
  • Pregnancy
  • Patients with allegies to the drugs used in this study

研究组 & 干预措施

not used intraoperative remifentanil infusion

Experimental

Adult patients aged < 70 years and ASA class < III undergoing rotator cuff repair not used intraoperative remifentanil infusion

干预措施: Not used remifentanil infusion (Drug)

结局指标

主要结局

Total infused dose of patient controlled analgesia(PCA) drug during 24 hours

时间窗: From end of operation to the 24hours after operation

Total infused dose of patient controlled analgesia(PCA) drug during first 24 hours after rotor cuff repair under general anesthesia

次要结局

  • Total patient's trial to PCA bolus infusion(24 hours after surgery)
  • Numerical Ratings Scale(Pain levels are checked using Numerical Ratings Scale at 4 hour intervals for 24 hours after surgery)
  • Incidence of postoperative nausea and vomiting(24 hours after surgery)

研究者

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

Jin-Tae Kim

Professor

Seoul National University Hospital

研究点 (1)

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