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临床试验/NCT04965194
NCT04965194已完成不适用

Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparotomies: Randomized Controlled Study

Minia University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Total analgesic consumption

研究概览

简要总结

The study aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies.

This prospective randomized controlled study will be done after obtaining ethics committee's permission and written informed consent of the patients 60 adult patients aged 18-60 years scheduled for open laparotomies under general anesthesia will be included in this study.

According to the used technique, the patients will be randomly allocated into 3 parallel equal groups (20 patients in each one).

Group I (ES group): the patients will receive bilateral ESP block. Group II (QL group): the patients will receive bilateral QL block. Group III (control group): the patients will not receive any regional block.

详细描述

Postoperative pain management is one of the most important issues influencing the outcome of surgery. Postoperative pain, especially when poorly controlled, results in harmful acute effects such as adverse physiological responses and chronic effects like delayed long term recovery and chronic pain.the investigators aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies.

Primary outcome:

Total analgesic consumption in the first 24hrs postoperative.

Secondary outcomes:

  1. Time of first analgesic request.
  2. Visual analogue pain score in the first 24hrs postoperative
  3. Incidence of any side effects. All patients will be premedicated using midazolam 0.03 mg /kg iv upon arrival to the operating room then standard monitoring which included SPO2, ECG, non-invasive blood pressure monitoring will be applied. All patients will receive the same anesthetic technique. Following anesthesia induction using 1-2 mcg/kg fentanyl, 2- 3 mg/kg propofol, and 0.5 mg/kg atracurium, the patients will be intubated and maintenance of anesthesia will be done by Isoflurane (MAC 1.2) and intermittent doses of atracurium to maintain adequate muscle relaxation. All hemodynamics will be measured before and after induction of general anesthesia and then every 5 min till end of surgery.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-60 years.
  • ASA I-II.
  • Both sexes.
  • Open laparotomies.

排除标准

  • Patient refusal
  • Allergy to local anesthetics
  • BMI >40 kg/m2
  • Bleeding diathesis or history of anticoagulant use.
  • Psychiatric diseases.
  • Infection of the skin at the site of needle punctures area.

结局指标

主要结局

Total analgesic consumption

时间窗: 24 hours

total fentanyl consumption as rescue analgesia

次要结局

  • dynamic Visual analogue pain score(24 hours)
  • resting Visual analogue pain score(24 hours)
  • Time of first analgesic request.(24 hours)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shadwa Rabea Mohamed

lecturer

Minia University

研究点 (2)

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