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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Elective Laparoscopic Cholecystectomy; Opioid-Free Anesthesia
• Intervention / Treatment: Other: opoid free 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

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ola Mahmoud Wahba Gnedy, Assistant Prof.; Phone Number: +2 01151121981; Email: ola.genadi@med.aun.edu.eg
• Study Contact Backup: Name: Mohamed Bakr Eid, prof; Phone Number: +2 01223213370; Email: bakr@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OpioidSparingGroup OS)	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; Other Names: Lidocaine; Magnesium; Dexmedetomidine
Active Comparator: ControlGroup (CG)	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; Other Names: Lidocaine; Magnesium; Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity at rest postoperatively (Visual Analog Scale, VAS, 0-10)	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.	48 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative opioid use (MME)	Cumulative opioid consumption will be measured in morphine milligram equivalents (MME) administered to each patient.	48 hours post operative
Time to extubating	Time to extubating; time to Aldrete ≥9	24 hours post operative
Time to first rescue analgesia	time to first demand for rescue analgesia	24 hours post operative
Bowel recovery (first flatus)	Time in hours from completion of surgery until the patient passes first flatus, representing bowel recovery.	48 hours post operative
Ambulation tolerance	Assessment of the patient's ability to ambulate, measured as distance walked in feet or meters within specified postoperative periods.	48 hours post operative

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Aldrete, J. A. (1995). The post-anesthesia recovery score revisited. Journal of Clinical Anesthesia, *7*(1), 89-91.
• .National Institutes of Health. HEAL Initiative: Preventing Opioid Use Disorder After Surgery. NIH Guide NOT-DA-22-052. 2022.
• . Huskisson, E. C. (1974). Measurement of pain. The Lancet, *304*(7889), 1127-1131.

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: October 17, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: opa
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Inorganic Chemicals; Elements; Metals, Light; Metals; Metals, Alkaline Earth; Lidocaine; Dexmedetomidine; Magnesium
• Other Study ID Numbers: 211198 (Registry Identifier: galal eldeen hasan hasan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No