Obese Patients
Conditions
Brief summary
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.
Interventions
DRUGInvestigatore 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.
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.
OTHERBilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).
Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-60 years. * BMI ≥ 35 kg/m². * ASA physical status II or III. * Scheduled for elective laparoscopic Roux en Y gastric bypass. * Ability to provide written informed consent.
Exclusion criteria
* 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). * Second or third degree AV block or significant bradyarrhythmia without pacemaker. * Coagulopathy, anticoagulation incompatible with regional anesthesia, or infection at block site. * Pregnancy or lactation. * Severe psychiatric or cognitive disorder. * Failed bilateral EOIB (absence of sensory loss in T6-T10 after 30 min) - excluded from analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total intraoperative fentanyl consumption | Intraoperative time, during surgery | Total intraoperative fentanyl consumption (μg) = loading dose (1 μg/kg) + rescue boluses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morphine consumption | The first 24 hours | Postoperative morphine consumption (mg) at 24 hours. |
| First rescue fentanyl and time to first postoperative morphine | The first 24 hours | Time to first rescue fentanyl (from induction to first bolus) and Time to first postoperative morphine (from PACU arrival to first dose). |
| Pain scores | Upon arrival, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours. | Pain scores (VAS score ranging 0-100) at Post Anesthetic Care Unit arrival, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours. |
Countries
Egypt
Contacts
CONTACTNevine Mostafa Soliman
Outcome results
None listed