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Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2026-04
Completion Date
2027-07-30
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
rachi morphine anesthesia
Morphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room.
laparotomy
major digestive or abdominal surgery by laparotomy
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.
Placebo
Sodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride.
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.
Locations (1)
Hôpital Privé Jean Mermoz
Lyon, France