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

NCT07306910 | Not Yet Recruiting

• 1 other identifier: 211198
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To evaluate the efficacy of a standardized multimodal Opioid Sparing (OS) protocol versus conventional opioid-based analgesia in reducing acute postoperative
2. 2.To quantify opioid consumption reduction achievable through OS strategies
3. 3.To assess the impact of OS on hemodynamic parameters during critical surgical phases
4. 4.To compare recovery metrics (PONV, bowel function, ambulation)
5. 5.To evaluate the safety profile of OS anesthesia

Conditions

Opioid-Free Anesthesia; Elective Laparoscopic Cholecystectomy

Keywords

opa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cumulative opioid use (MME)

  48 hours post operative

• Time to extubating

  24 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

Study Arms (2)

OpioidSparingGroup OS)

ACTIVE COMPARATOR

Other: opoid free anesthesia

ControlGroup (CG)

ACTIVE COMPARATOR

Other: opoid free anesthesia

Interventions

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

Also known as: Lidocaine, Dexmedetomidine, Magnesium

ControlGroup (CG); OpioidSparingGroup OS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related 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.

MeSH Terms

Interventions

Lidocaine; Dexmedetomidine; Magnesium

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Central Study Contacts

Ola Mahmoud Wahba Gnedy, Assistant Prof.

CONTACT

01151121981; ola.genadi@med.aun.edu.eg

Mohamed Bakr Eid, prof

CONTACT

01223213370; bakr@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Blinding: Participants, anesthetist/ clinicians obserevers and data analysts will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at the anesthesia , icu and pain management department

Model Details: Type of the study: Prospective, triple-blind, parallel-group, superiority block randomized controlled trial. Study Setting and design features. • Allocation: Computer-generated 1:1 block randomization with allocation concealment (block size = 6), stratified by ASA status (I vs II/III).

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: December 29, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12