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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

July 30, 2027

Study Completion Date

July 30, 2027

Conditions
Digestive System DiseaseSurgery
Interventions
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.

Trial Locations (1)

69008

Hôpital Privé Jean Mermoz, Lyon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Euraxi Pharma

INDUSTRY

lead

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

NCT07076641 - Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia | Biotech Hunter | Biotech Hunter