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

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.

Inclusion criteria

• Age ≥ 18 years;
• Major digestive or abdominal surgery (pancreatic, hepatic, colorectal, gynecological, esophageal, gastric, duodenal, small intestine...);
• Scheduled surgery;
• Laparotomy;
• Patient in agreement with morphine rachi anesthesia;
• Social security affiliation;
• Signed informed consent.

Exclusion criteria

• 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 ;
• Myocardial infarction <6 months;
• Severe cardiocirculatory insufficiency;
• Severe hepatic insufficiency;
• Allergy to morphine ;
• Allergy to lidocaine;
• Rhythm disorders at risk of sudden death (e.g. Brugada syndrome);
• Flecaine as usual treatment;
• Chronic pain with level II or III analgesics;
• Gabapentinoids: pregabalin (Lyrica), gabapentin;
• Drug addiction and substitute drugs;
• Epileptic disorders ;
• Myasthenia gravis;
• Creatinine clearance below 10 mL/min;
• Hypokalemia, hypoxia or acid-base disorders;
• Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
• Inability to understand study information (due to linguistic, psychological, cognitive or literacy problems);
• Women who are or may become pregnant* (of childbearing age, without effective contraception) or who are breast-feeding;
• Patient deprived of liberty, under guardianship or unable to give consent.