About this trial
Adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption (ANI guided rescue) compared to placebo, without increasing adverse events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-60 years.
BMI ≥ 35 kg/m².
ASA physical status II or III.
Scheduled for elective laparoscopic Roux en Y gastric bypass.
Disqualifiers
Refusal.
Allergy or contraindication to lidocaine, fentanyl, ropivacaine, or any study medication.
Chronic opioid use or dependence.
Significant hepatic (AST/ALT> 3× normal, cirrhosis) or renal impairment (CrCl< 30 mL/min).
Trial design
Parallel
Treatments tested in this trial
Investigatore hypothesize that adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption.
DrugAdding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption (ANI guided rescue) compared to placebo, without increasing adverse events.
Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).
Other interventionBilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).
Treatment groups
Trial outcomes
Primary outcomes
Total intraoperative fentanyl consumption
Total intraoperative fentanyl consumption (μg) = loading dose (1 μg/kg) + rescue boluses.
Secondary outcomes
Postoperative morphine consumption
Postoperative morphine consumption (mg) at 24 hours.
First rescue fentanyl and time to first postoperative morphine
Time to first rescue fentanyl (from induction to first bolus) and Time to first postoperative morphine (from PACU arrival to first dose).
Pain scores
Pain scores (VAS score ranging 0-100) at Post Anesthetic Care Unit arrival, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours.
Sponsors and contacts
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