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NCT Number: NCT07809425

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

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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Key information

Conditions

Obese Patients

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

Primary outcomes

  1. Total intraoperative fentanyl consumption

    Time frame: Intraoperative time, during surgery

    Total intraoperative fentanyl consumption (μg) = loading dose (1 μg/kg) + rescue boluses.

Secondary outcomes

  1. Postoperative morphine consumption

    Time frame: The first 24 hours

    Postoperative morphine consumption (mg) at 24 hours.

  2. First rescue fentanyl and time to first postoperative morphine

    Time frame: 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).

  3. Pain scores

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nevine Mostafa Soliman

CONTACT

[email protected]

+201128861471

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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