跳至主要内容
临床试验/NCT04183244
NCT04183244Unknown1 期

Efficacy of Erector Spinae Plane Block Versus Infraclavicular Subomohyoid Block in Shoulder Surgery: A Randomized Controlled Blinded Study

Ain Shams University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年8月15日最近更新:
适应症

试验速览

阶段
1 期
入组人数
80
试验地点
2
主要终点
The block efficacy

研究概览

简要总结

The study aimed to compare Erector Spinae Plane (ESP) block versus infraclavicular subomohyoid (ISO) block in the provision of efficacy of either technique in postoperative analgesia in shoulder surgery, aiming to testing the safety of each block in terms of incidence of complications. Patients will be randomly divided into two groups, Group E will receive Erector spinae block and group I will receive infraclavicular subomohyioid block. The local anesthetic solution that will be used in both blocks will be a total volume of 30 mls 0.25%bupivacaine plus 3mg preservative free Dexamethasone. The time between recovery from anesthesia and first pain experienced, as verified by NRS ≥ 3 and first need of a rescue analgesic, will be defined as the duration of analgesia. The total dose of intravenous morphine (the rescue analgesic) used over 24 h postoperatively 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
Single (Investigator)

入排标准

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

入选标准

  • Adult patients, above 18 years old.
  • ASA physical status I
  • Scheduled for shoulder surgery

排除标准

  • Morbid obese.
  • Previous surgery in the same shoulder.
  • History of psychiatric disorder.
  • Pulmonary disease.
  • Contraindication to regional nerve block (e.g. skin infection at the puncture site, coagulopathy).
  • Allergy to any of medications that will be used

结局指标

主要结局

The block efficacy

时间窗: 24 hours

Percentage of 24 hours pain free patients

次要结局

  • The incidence of expected complications ( Block safety)(24 hours)

研究者

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

Randa Ali Shoukry

Assistant Professor

Ain Shams University

研究点 (2)

Loading locations...

相似试验