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临床试验/NCT04835415
NCT04835415已完成不适用

Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy

Zagazig University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年4月10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
52
试验地点
1
主要终点
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)

研究概览

简要总结

The aim of this study is to evaluate analgesic effect of ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia in pain control following laparoscopic cholecystectomy.

详细描述

To study the difference between the effects of ultrasound-guided bilateral retrolaminar block and ultrasound-guided thoracic epidural analgesia on pain control following laparoscopic cholecystectomy. To relief pain and improve satisfaction in patients undergoing laparoscopic cholecystectomy at Zagazig university hospitals.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double (participant, outcomes assessor) Anesthetist not sharing in the study will assess patient.

入排标准

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

入选标准

  • Written informed consent from the patient.
  • Age: 21-45 years old.
  • Sex: both sex (males and females).
  • Physical status: ASA 1& II.
  • BMI = (25-35 kg/m2).
  • Type of operation: elective laparoscopic cholecystectomy

排除标准

  • Altered mental state.
  • Patients with known history of allergy to study drugs.
  • Advanced hepatic, renal, cardiovascular, and respiratory diseases.
  • Patients with chronic pain.
  • Patients receiving anticoagulants.
  • Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

结局指标

主要结局

Pain intensity at rest and at cough using Numerical Rating Scales (NRS)

时间窗: at 12 hours postoperative

measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)

次要结局

  • Total analgesic (Naluphine) consumption(within 12 hours postoperative)
  • Time to first call of rescue analgesia(within 12 hours postoperative)
  • The number of participant with nausea, vomiting, hypotension and bradycardia.(24 hours postoperative)
  • The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)(within 24 hours postoperative)
  • Patient satisfaction is recorded at the end of 24 hours postoperative(24 hours postoperative)

研究者

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

Dina Abdelhameed Elsadek Salem

Principle investigator

Zagazig University

研究点 (1)

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