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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMenoufia University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-60 years.

BMI ≥ 35 kg/m².

ASA physical status II or III.

Scheduled for elective laparoscopic Roux en Y gastric bypass.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group L (lidocaine)Active comparator 1 intervention
Group B: Group P (placebo)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total intraoperative fentanyl consumption

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

Time frame
Intraoperative time, during surgery

Secondary outcomes

1

Postoperative morphine consumption

Postoperative morphine consumption (mg) at 24 hours.

Time frame
The first 24 hours
2

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).

Time frame
The first 24 hours
3

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.

Time frame
Upon arrival, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours.

Other outcomes

Sponsors and contacts

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