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

Assiut University

Status: Not yet enrolling

Conditions: Opioid-Free Anesthesia; Elective Laparoscopic Cholecystectomy

Treatments: Other: opoid free anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07306910

211198 (Registry Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups

OpioidSparingGroup OS)

Active Comparator group

Treatment:

Other: opoid free anesthesia

ControlGroup (CG)

Active Comparator group

Treatment:

Other: opoid free anesthesia