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临床试验/NCT07750769
NCT07750769尚未招募不适用

Analgesic Efficacy of Opioid-Free Anesthesia Protocol Combined With Ultrasound-Guided External Oblique Intercostal Plane Block for Laparoscopic Cholecystectomy: A Prospective Randomized Comparative Study

Assiut University0 个研究点目标入组 70 人开始时间: 2026年10月15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
尚未招募
入组人数
70
主要终点
the amount of fentanyl consumption used for pain relief in the first six hours after laparoscopic cholecystectomy (LC) under general anesthesia

研究概览

简要总结

laparoscopic cholecystectomy (LC) is often accompanied by moderate-to-severe postoperative pain. opioid-free anesthesia (OFA) consists of a variety of non-opioid narcotic drugs and techniques.

详细描述

opioid-free anesthesia (OFA) can control postoperative pain effectively and reduce opioid drug consumption.

The external oblique intercostal plane (EOI) block is easy to perform and may provide effective analgesia for laparoscopic cholecystectomy.

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

  • Adult patients scheduled for elective laparoscopic cholecystectomy (LC) surgery under general anesthesia, American Society of Anesthesiologists (ASA) physical status I-II, aged from 18 to 65 years old of either sex

排除标准

  • Contraindications to regional block (coagulopathy, infection at the needle insertion site, or known allergy to amide local anesthetics)
  • Pregnancy or breastfeeding women
  • Body mass index (BMI) > 35 Kg/m2
  • History of hepatic, renal, or cardiac disease
  • Chronic opioid use, or history of chronic pain (pain present for more than 6 months)
  • Thoracic deformity
  • Neuropsychiatric disorders
  • Patient refusal.

研究组 & 干预措施

Group I

Active Comparator

Patients will receive ultrasound-guided external oblique intercostal plane (EOI) block added to an opioid-free anesthesia (OFA) protocol

干预措施: EOI with OFA (Procedure)

Group II

Placebo Comparator

Patients will receive an opioid-free anesthesia (OFA) protocol

干预措施: OFA (Drug)

结局指标

主要结局

the amount of fentanyl consumption used for pain relief in the first six hours after laparoscopic cholecystectomy (LC) under general anesthesia

时间窗: The first six hours after surgery

Assessed in microgram

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

Seham Mohamed Moeen Ibrahim

Assiut University

Assiut University

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