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临床试验/NCT04637386
NCT04637386已完成不适用

the Efficacy of Transversus Abdominis Plane Block for Analgesia in Comparison With Local Anesthetic Wound Infiltration Post-cesarean Section: A Randomized Comparative Double-blinded Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
degree of pain at rest and on movement (hip flexion and coughing) at 2, 4, 6, 12, and 24 hours postoperatively

研究概览

简要总结

Adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the TAP block would decrease postoperative pain and postoperative cumulative opioid consumption at 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
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who underwent cesarean section under spinal anesthesia.
  • Aged ≥19 years and less than 40 years.
  • Gestational age ≥ 37 Weeks.

排除标准

  • Body mass index (BMI) ≥40 kg/m
  • History of recent opioid exposure
  • Hypersensitivity to any of the drugs used in the study.
  • Significant cardiovascular, renal, or hepatic disease

结局指标

主要结局

degree of pain at rest and on movement (hip flexion and coughing) at 2, 4, 6, 12, and 24 hours postoperatively

时间窗: 24 hours

, using a visual analog scale (VAS) score for pain intensity reported on 0-10-point scale for analysis. (0 = no pain and 10 = the worst possible pain).

次要结局

  • measures the time to the first postoperative opioid dose(24 hours)

研究者

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

ahmed nagy shaker ramadan

assistant lecture of obstetrics and gynecology

Cairo University

研究点 (2)

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