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NCT Number: NCT07306910

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

opoid free anesthesia

Other

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

Other names: Lidocaine, Dexmedetomidine, Magnesium

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Cumulative opioid use (MME)

    Time frame: 48 hours post operative

    Cumulative opioid consumption will be measured in morphine milligram equivalents (MME) administered to each patient.

  2. Time to extubating

    Time frame: 24 hours post operative

    Time to extubating; time to Aldrete ≥9

  3. Time to first rescue analgesia

    Time frame: 24 hours post operative

    time to first demand for rescue analgesia

  4. Bowel recovery (first flatus)

    Time frame: 48 hours post operative

    Time in hours from completion of surgery until the patient passes first flatus, representing bowel recovery.

  5. Ambulation tolerance

    Time frame: 48 hours post operative

    Assessment of the patient's ability to ambulate, measured as distance walked in feet or meters within specified postoperative periods.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Bakr Eid, prof

CONTACT

[email protected]

01223213370 ext. +2

Ola Mahmoud Wahba Gnedy, Assistant Prof.

CONTACT

[email protected]

01151121981 ext. +2

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: OFA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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