NCT07076641

Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia

Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Analgesic Morphine Rachi Anesthesia for Major Digestive or Abdominal Surgery by Laparotomy.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the superiority of IV lidocaine combined with morphine spinal anesthesia versus placebo combined with morphine spinal anesthesia, in reducing postoperative morphine consumption at 48 hours, in patients undergoing major digestive or abdominal surgery by laparotomy.

Detailed description

This is a prospective, interventional, comparative, randomized, 2-group parallel, placebo-controlled, double-blind, single-center trial designed to evaluate the value of intravenous lidocaine combined with morphine rachi anesthesia in major laparotomy digestive or abdominal surgery. The study corresponds to a clinical trial of a medicinal product in compliance with Regulation (EU) n°536/2014. The study population is composed of adult patients receiving morphine spinal anesthesia for major laparotomy surgery and who have signed an informed consent form.

Conditions

• Digestive System Disease
• Surgery

Interventions

Type	Name	Description
PROCEDURE	rachi morphine anesthesia	Morphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room.
PROCEDURE	laparotomy	major digestive or abdominal surgery by laparotomy
DRUG	Lidocaine IV	KABI 20 mg/mL solution for injection (ready-to-use ampoule, no dilution). Each ml of solution contains 20 mg lidocaine hydrochloride (monohydrate form), corresponding to 16.22 mg lidocaine.
DRUG	Placebo	Sodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride.
DRUG	MORPHINE	The auxiliary drug on which both experimental strategies are based is MORPHINE: Morphine hydrochloride AGUETTANT 0.1 mg/mL Solution for injection (ready-to-use ampoule) for rachi anesthesia.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-07-30
• Completion: 2027-07-30
• First posted: 2025-07-22
• Last updated: 2026-03-30

Locations

1 site across 1 country: France