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.

• rachi morphine anesthesia (Procedure): Morphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room.
• laparotomy (Procedure): major digestive or abdominal surgery by laparotomy
• Lidocaine IV (Drug): 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 (Drug): Sodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride.
• MORPHINE (Drug): 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.

Primary outcomes

• Total morphine consumption [2 days]: 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.

Sex: All, ages: 18 Years to any

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.

NIH grants: 2025