External Oblique Intercostal Block With or Without Intravenous Lidocaine Infusion for Analgesia in Patients Undergoing Gastric Bypass Surgery
Recruiting · NCT07809425 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).We 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.
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Faculty of Medicine - Alexandria, Egypt