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.

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.

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.