Effect of Opioid-Free Anesthesia (OFA) on Postoperative Pain and Perioperative Nausea and Vomiting in Elective Laparoscopic Cholecystectomy.
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
- To evaluate the efficacy of a standardized multimodal Opioid Sparing (OS) protocol versus conventional opioid-based analgesia in reducing acute postoperative
- To quantify opioid consumption reduction achievable through OS strategies
- To assess the impact of OS on hemodynamic parameters during critical surgical phases
- To compare recovery metrics (PONV, bowel function, ambulation)
- 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
- 是
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
Galal Eldeen Hasan Hasan Hussein
resident at the anesthesia , icu and pain management department
Assiut University