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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • opoid free anesthesia

    Other intervention

    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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: OpioidSparingGroup OS)Active comparator 1 intervention
Group B: ControlGroup (CG)Active comparator 1 intervention

Trial outcomes

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.

Time frame
48 hours post operative

Secondary outcomes

1

Cumulative opioid use (MME)

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

Time frame
48 hours post operative
2

Time to extubating

Time to extubating; time to Aldrete ≥9

Time frame
24 hours post operative
3

Time to first rescue analgesia

time to first demand for rescue analgesia

Time frame
24 hours post operative
4

Bowel recovery (first flatus)

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

Time frame
48 hours post operative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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