External Oblique Intercostal Block With or Without Intravenous Lidocaine Infusion for Analgesia in Patients Undergoing Gastric Bypass Surgery

NCT07809425 — Not applicable, Recruiting, 100 participants, Menoufia University

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External Oblique Intercostal Block With or Without Intravenous Lidocaine Infusion for Analgesia in Patients Undergoing Gastric Bypass Surgery: a Randomized Controlled Trial

Registry	NCT07809425
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	100 (Estimated)
Sponsor	Menoufia University (Other)
Conditions	Obese Patients
Interventions	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., Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate). (Drug, other)
Dates	start 2026-09-15 (estimated), primary completion 2027-01-15 (estimated), completion 2027-02-01 (estimated), first posted 2026-09-09, last updated 2026-09-11
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group L (lidocaine)	Active comparator	Drug: 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.	Bilateral EOIB + fentanyl 1 μg/kg loading + lidocaine 1.5 mg/kg loading + lidocaine infusion 1.5 mg/kg/h.
Group P (placebo)	Placebo comparator	Other: Bilateral 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).

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. (Drug): 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.
Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate). (Other): Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).

+Outcome measures

Primary outcomes

Total intraoperative fentanyl consumption [Intraoperative time, during surgery]: Total intraoperative fentanyl consumption (μg) = loading dose (1 μg/kg) + rescue boluses.

Secondary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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.

+Locations (1)

Facility	City	Country	Status
Faculty of Medicine	Alexandria	Egypt	Recruiting