External Oblique Intercostal Block With or Without Lidocaine for Pain After Gastric Bypass

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial examines if a perioperative lidocaine infusion (loading dose 1.5 mg/kg followed by 1.5 mg/kg/h) added to bilateral external oblique intercostal blocks and a low-dose fentanyl loading reduces intraoperative fentanyl needs compared with placebo, without increasing adverse events. Participants are adults aged 18–60 with BMI ≥35 kg/m² and undergoing elective laparoscopic Roux-en-Y gastric bypass. The intervention group receives lidocaine infusion and EOIB with fentanyl loading, while the control receives normal saline in place of lidocaine and similar regional anesthesia. Outcomes focus on intraoperative fentanyl consumption and safety signals, with ANI-guided rescue allowed as per protocol. Exclusion criteria include lidocaine allergy, chronic opioid use, hepatic or renal impairment, certain cardiac conditions, pregnancy, coagulopathy, infection at block site, and failed EOIB. Lead sponsor is Menoufia University, with a single site in Alexandria, Egypt.

Why it matters

Who can join: the full rules

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's running

• Faculty of Medicine
  Alexandria, Egypt Recruiting

Study contacts

• Study coordinator: Nevine Mostafa Soliman
• Email: mostafanevine@gmail.com
• Phone: +201128861471

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.