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临床试验/NCT06564610
NCT06564610已完成不适用

Laparoscopic Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年8月25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
96
试验地点
1
主要终点
Numerical rating scale

研究概览

简要总结

The aim of this work is to compare the analgesic efficacy of laparoscopic transversus abdominis plane block, performed by the surgeon to ultrasound-guided erector spinae plane block, performed by the anesthetist, in patients with obesity undergoing bariatric surgery.

详细描述

This is a randomized controlled trial which will include patients with obesity undergoing bariatric surgery. The patients will be randomly allocated into two groups: transversus abdominis plane block group and erector spinae plane block group. The block will be performed after induction of general anesthesia. Preoperative evaluation and preparation will include history-taking, laboratory investigation, fasting recommendations, and optimization of the medical status. The two groups will receive standard induction and maintenance of anesthesia. After the end of the operation, patients will receive standard care according to the local protocols and the enhanced recovery recommendations. Patients will be monitored according to the pain-related outcomes as well as hemodynamic parameters.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with obesity undergoing laparoscopic bariatric surgery under general anesthesia.

排除标准

  • Allergy to local anaesthetic.
  • Bleeding disorders.
  • Obstructive sleep apnea.
  • inability to understand the numerical rating scale for pain assessment.

研究组 & 干预措施

Transversus abdominis block

Experimental

Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.

干预措施: Bariatric surgery (Procedure)

Transversus abdominis block

Experimental

Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.

干预措施: Endotracheal intubation (Device)

Transversus abdominis block

Experimental

Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.

干预措施: Transversus abdominis block (Procedure)

Transversus abdominis block

Experimental

Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.

干预措施: Propofol (Drug)

Erector spinae block

Active Comparator

Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.

干预措施: Erector spinae block (Procedure)

Erector spinae block

Active Comparator

Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.

干预措施: Bariatric surgery (Procedure)

Erector spinae block

Active Comparator

Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.

干预措施: Endotracheal intubation (Device)

Erector spinae block

Active Comparator

Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.

干预措施: Propofol (Drug)

结局指标

主要结局

Numerical rating scale

时间窗: 24 hours after surgery

This is a scale for pain assessment which ranges between 0 and 10 with the highest level of pain having score 10 and lowest level of pain having score 0

次要结局

  • Consumption of analgesia(24 hours after surgery)
  • Heart rate(24 hours after surgery)
  • Vomiting(24 hours)
  • Systolic blood pressure(24 hours after surgery)
  • Diastolic blood pressure(24 hours)

研究者

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

Ahmed Hasanin

Professor

Cairo University

研究点 (1)

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