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临床试验/NCT06640062
NCT06640062已完成不适用

Evaluation of Ultrasound-Guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Comparative Study

Helwan University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023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
50
试验地点
2
主要终点
Degree of pain intensity

研究概览

简要总结

The aim of this work was to compare the effect of using oblique subcostal transversus abdominis plane (OSTAP) block and erector spinae plane (ESP) block as a part of multi-modal analgesia technique in patients undergoing laparoscopic cholecystectomy.

详细描述

Laparoscopic cholecystectomy is a commonly performed surgery and requires multi-modal analgesia for better control of pain. Untreated post-operative pain has many consequences, including patient dissatisfaction, transition into chronic pain, delayed discharge from the hospital, and increased healthcare costs.

Many inter-fascial plane blocks like oblique subcostal transversus abdominis plane (OSTAP) block and recently, erector spinae plane (ESP) block have been utilized as a part of multi modal analgesia technique in many abdominal surgeries.

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
Single (Participant)

入排标准

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

入选标准

  • Age from 20 to 60 years.
  • Both gender.
  • American Society of Anesthesiologists (ASA) grade I and II physical status.
  • Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m
  • Underwent laparoscopic cholecystectomy.

排除标准

  • Patient refusal.
  • Known sensitivity or contraindication to drugs used in the study (local anesthetics, opioids).
  • History of psychological disorders and/or chronic pain syndrome.
  • Contraindication to regional anesthesia, e.g., local sepsis, pre-existing peripheral neuropathies, and coagulopathy.
  • Severe respiratory disorders such as (severe obstructive pulmonary disease, forced expiratory volume (FEV1), forced vital capacity (FVC) <50% or severe restrictive pulmonary disease, and adult respiratory distress syndrome).
  • Severe cardiac disorders such as (heart failure).
  • Advanced liver disease (elevated liver enzymes more than 3 folds of normal range).
  • Advanced kidney disease (Decreased creatinine clearance <40 ml/min).
  • Pregnancy.

结局指标

主要结局

Degree of pain intensity

时间窗: 24 hours postoperatively

The degree of pain intensity was assessed using the Visual Analogue Scale (VAS). Each patient was instructed about postoperative pain assessment with the VAS. VAS(0 represents "no pain" while 10 represents "the worst pain imaginable"). It was assessed at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.

次要结局

  • Incidence of adverse effects of the block technique(24 hours postoperatively)
  • Time to first rescue analgesia(24 hours postoperatively)
  • Total amount of morphine consumption(24 hours postoperatively)
  • Morphine-related side effects(24 hours postoperatively)
  • Local anesthetics-related side effects(24 hours postoperatively)

研究者

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

Michael Fayez Yousef Metias

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Helwan University, Egypt.

Helwan University

研究点 (2)

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