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临床试验/NCT07306910
NCT07306910
尚未招募
不适用

Effect of Opioid-Free Anesthesia (OFA) on Postoperative Pain and Perioperative Nausea and Vomiting in Elective Laparoscopic Cholecystectomy.

Assiut University0 个研究点目标入组 110 人开始时间: 2025年12月30日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
110
主要终点
Pain intensity at rest postoperatively (Visual Analog Scale, VAS, 0-10)

概览

简要总结

  1. To evaluate the efficacy of a standardized multimodal Opioid Sparing (OS) protocol versus conventional opioid-based analgesia in reducing acute postoperative
  2. To quantify opioid consumption reduction achievable through OS strategies
  3. To assess the impact of OS on hemodynamic parameters during critical surgical phases
  4. To compare recovery metrics (PONV, bowel function, ambulation)
  5. To evaluate the safety profile of OS anesthesia

详细描述

The ongoing opioid crisis represents a significant public health challenge, with surgical prescriptions being a major contributor to chronic opioid use and misuse. Recent epidemiological data indicate that 4-6% of opioid- naïve patients develop persistent opioid use postoperatively, with laparoscopic cholecystectomy patients being particularly vulnerable due to moderate postoperative pain . Despite being a minimally invasive procedure, laparoscopic cholecystectomy consistently ranks among the most common general surgical procedures worldwide, with over 1 million performed annually in the United States alone. This frequency amplifies the population-level impact of postoperative prescribing patterns . Previous studies have demonstrated the efficacy of individual components-dexmedetomidine for hemodynamic stabilization, lidocaine infusions for visceral analgesia, and regional techniques like erector spinae plane (ESP) blocks-but their synergistic effects remain underexplored . A recent scoping review highlighted that while opioid-sparing (OS) effects are frequently reported, evidence for clinically meaningful outcomes (e.g., reduced ventilation time, accelerated functional recovery) remains limited . The pathophysiology of post-cholecystectomy pain involves both somatic (abdominal wall) and visceral (diaphragmatic irritation, biliary spasm) components, necessitating a multimodal approach. Opioids inadequately address inflammatory mediators while introducing risks of respiratory depression, postoperative nausea and vomiting (PONV), ileus, and hemodynamic instability. Emerging evidence suggests that α-2 agonists (e.g., dexmedetomidine) and NMDA ant

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Blinding: Participants, anesthetist/ clinicians obserevers and data analysts will be blinded to group allocation.

入排标准

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

入选标准

  • Adults aged 18 to 60 years scheduled for elective laparoscopic cholecystectomy. Elective must be included in title.
  • ASA (American Society of Anesthesiologists) physical status I or II.
  • Body Mass Index (BMI) \< 35 kg/m².

排除标准

  • Chronic opioid use (\>30 MME/day for \>3 months).
  • Contraindications to study medications (e.g., severe hepatic impairment; allergy/contraindication to lidocaine, dexmedetomidine, ketamine, fentanyl, or NSAIDs).
  • Renal dysfunction (eGFR \<60 mL/min/1.73 m²).
  • Significant cardiac conduction abnormalities.
  • Pregnancy or lactation.
  • Emergency surgery or conversion to open cholecystectomy

结局指标

主要结局

Pain intensity at rest postoperatively (Visual Analog Scale, VAS, 0-10)

时间窗: 48 hours post operative

Pain intensity at rest will be measured using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.

次要结局

  • Time to extubating(24 hours post operative)
  • Cumulative opioid use (MME)(48 hours post operative)
  • Time to first rescue analgesia(24 hours post operative)
  • Bowel recovery (first flatus)(48 hours post operative)
  • Ambulation tolerance(48 hours post operative)

研究者

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

Galal Eldeen Hasan Hasan Hussein

resident at the anesthesia , icu and pain management department

Assiut University

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