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

Launched by GCS RAMSAY SANTÉ POUR L'ENSEIGNEMENT ET LA RECHERCHE · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether giving a medicine called lidocaine through a vein (intravenous) along with morphine spinal anesthesia can help reduce the amount of morphine needed after major digestive or abdominal surgery. Morphine spinal anesthesia is a way to control pain during surgery by putting morphine near the spinal cord. The study will compare patients who receive lidocaine plus morphine spinal anesthesia to those who get a placebo (a treatment with no active medicine) plus morphine spinal anesthesia. The main goal is to see if lidocaine helps reduce the need for morphine in the first 48 hours after surgery.

Adults aged 18 and older who are scheduled for major planned digestive or abdominal surgery through an open cut (called laparotomy) may be able to join. This includes surgeries on organs like the pancreas, liver, intestines, stomach, or female reproductive organs. To participate, patients must agree to receive morphine spinal anesthesia and be able to give informed consent. People with certain health issues—such as emergency surgery, kidney or liver problems, heart rhythm disorders, allergies to morphine or lidocaine, or those who are pregnant or breastfeeding—would not be eligible. If you join the study, you can expect to receive standard care for your surgery plus either lidocaine or a placebo through an IV, and the research team will carefully monitor your pain levels and morphine use after surgery. This study is not yet recruiting patients.

Gender

ALL

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.