NCT07306910

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

Conditions

• Opioid-Free Anesthesia
• Elective Laparoscopic Cholecystectomy

Interventions

Type	Name	Description
OTHER	opoid free anesthesia	Maintenance Dexmedetomidine 0.2-0.5 µg/kg/h + Lidocaine 1.5 mg/kg/h + Magnesium 10 mg/kg/h; Sevoflurane as required; Atracurium 0.1 mg/kg IV PRN

Timeline

• Start date: 2025-12-30
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2025-12-29
• Last updated: 2025-12-29