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

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

Study Overview

• Status: Recruiting
• Conditions: Obese Patients
• Intervention / Treatment: Drug: 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.; Other: Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nevine Mostafa Soliman; Phone Number: +201128861471; Email: mostafanevine@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • faculty of Medicine
    • Contact: Nevine Mostafa Soliman; Phone Number: +201128861471; Email: mostafanevine@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group L (lidocaine); Bilateral EOIB + fentanyl 1 μg/kg loading + lidocaine 1.5 mg/kg loading + lidocaine infusion 1.5 mg/kg/h.	Drug: 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.; 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.
Placebo Comparator: Group P (placebo); 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).; Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative fentanyl consumption	Total intraoperative fentanyl consumption (μg) = loading dose (1 μg/kg) + rescue boluses.	Intraoperative time, during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morphine consumption	Postoperative morphine consumption (mg) at 24 hours.	The first 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).	The first 24 hours
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.	Upon arrival, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours.

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: August 30, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Fentanyl
• Other Study ID Numbers: 8/2026ANET3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No