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.
Age ≥ 18 years;
Major digestive or abdominal surgery (pancreatic, hepatic, colorectal, gynecological, esophageal, gastric, duodenal, small intestine...);
Scheduled surgery;
Laparotomy;
Emergency surgery;
Contraindication to non-steroidal anti-inflammatory drugs: history of gastro duodenal ulcer, renal failure from stage 3 A or higher;
History of bradycardia and/or known conduction disorder (atrioventricular block) / Pacemaker ;
Unstable coronary ;
Parallel
rachi morphine anesthesia
Procedure/SurgeryMorphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room.
laparotomy
Procedure/Surgerymajor digestive or abdominal surgery by laparotomy
Lidocaine IV
DrugKABI 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
DrugSodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride.
MORPHINE
DrugThe 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.
Total morphine consumption
Total consumption of morphine received postoperatively from the post-interventional monitoring room to 48 hours (in mg) by intravenous and patient-controlled analgesia, and oral dose converted to IV morphine equivalent where applicable.
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GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead sponsor
Euraxi Pharma
Collaborator
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