Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rachi morphine anesthesia, laparotomy, Lidocaine IV, Placebo.
- Who it may be relevant to
- Registry conditions: Digestive System Disease, Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Detailed description
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.
Interventions
- Procedure rachi morphine anesthesia
Morphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room. - Procedure laparotomy
major digestive or abdominal surgery by laparotomy - Drug 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. - Drug Placebo
Sodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride. - Drug 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.
Primary outcome measures
- Total morphine consumption [Time frame: 2 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hôpital Privé Jean Mermoz — Lyon
Identifiers
NCT: NCT07076641 · 2025-521206-18-00