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临床试验/NCT06292832
NCT06292832尚未招募不适用

Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Pain Control After Cesarean Section in Obese and Morbidly Obese Women

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年3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
尚未招募
入组人数
68
试验地点
2
主要终点
postoperative time to rescue analgesia requirement

研究概览

简要总结

The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS.

详细描述

The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. The present study will include ASA I-II women scheduled for elective CS under intrathecal anesthesia. Patients will be excluded if they had local infection, bleeding disorder or known allergy to any of the study medications. This study defines obesity as body mass index (BMI) ≥ 30 kg/m2 while morbid obesity is defined as BMI ≥ 40 kg/m2 assessed in the last pre-pregnancy visit (Sagi-Dain et al., 2021). The study will include normal weight women (n=86), obese women (n=86) and morbidly obese women (n=86).

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-II women scheduled for elective CS under intrathecal anesthesia.

排除标准

  • had local infection, bleeding disorder or known allergy to any of the study medications

研究组 & 干预措施

Obese Transversus Abdominis Plane Block

Active Comparator

Transversus Abdominis Plane Block for pain control.

干预措施: Ultrasound-guided pain block (Procedure)

Obese Transversus Abdominis Plane Block

Active Comparator

Transversus Abdominis Plane Block for pain control.

干预措施: Ultrasound Machine (Device)

Obese Spinae Plane Block

Active Comparator

Spinae Plane Block for pain control

干预措施: Ultrasound-guided pain block (Procedure)

Obese Spinae Plane Block

Active Comparator

Spinae Plane Block for pain control

干预措施: Ultrasound Machine (Device)

Morbidly Obese Spinae Plane Block

Active Comparator

Spinae Plane Block for pain control

干预措施: Ultrasound-guided pain block (Procedure)

Morbidly Obese Spinae Plane Block

Active Comparator

Spinae Plane Block for pain control

干预措施: Ultrasound Machine (Device)

Morbidly Obese Transversus Abdominis Plane Block

Active Comparator

Transversus Abdominis Plane Block for pain control.

干预措施: Ultrasound-guided pain block (Procedure)

Morbidly Obese Transversus Abdominis Plane Block

Active Comparator

Transversus Abdominis Plane Block for pain control.

干预措施: Ultrasound Machine (Device)

结局指标

主要结局

postoperative time to rescue analgesia requirement

时间窗: 24 hours

Time

次要结局

未报告次要终点

研究者

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

Warda Demerdash Khalifa Ali

Principal investigator

Al-Azhar University

研究点 (2)

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