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

Not Applicable

Not yet recruiting

• Conditions: Digestive System Disease; Surgery
• Interventions: Procedure: rachi morphine anesthesia; Procedure: laparotomy; Drug: Lidocaine IV; Drug: Placebo; Drug: MORPHINE

• Registration Number: NCT07076641
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Study Start: 2025-08-01
• Primary Completion: 2027-07-30
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIDOCAINE Intravenous electric syringe	rachi morphine anesthesia	Induction bolus 1.5 mg/kg (adjusted weight) intraoperatively, at the time of anesthetic induction, 15 to 30 min before incision. Maintenance 1.5 mg/kg/h until end of care / discharge from the intensive care unit (reduced to 1 mg/kg/h in the post-interventional monitoring room), i.e. between 1 and 2 hours after the end of surgery.
LIDOCAINE Intravenous electric syringe	laparotomy	Induction bolus 1.5 mg/kg (adjusted weight) intraoperatively, at the time of anesthetic induction, 15 to 30 min before incision. Maintenance 1.5 mg/kg/h until end of care / discharge from the intensive care unit (reduced to 1 mg/kg/h in the post-interventional monitoring room), i.e. between 1 and 2 hours after the end of surgery.
LIDOCAINE Intravenous electric syringe	Lidocaine IV	Induction bolus 1.5 mg/kg (adjusted weight) intraoperatively, at the time of anesthetic induction, 15 to 30 min before incision. Maintenance 1.5 mg/kg/h until end of care / discharge from the intensive care unit (reduced to 1 mg/kg/h in the post-interventional monitoring room), i.e. between 1 and 2 hours after the end of surgery.
LIDOCAINE Intravenous electric syringe	MORPHINE	Induction bolus 1.5 mg/kg (adjusted weight) intraoperatively, at the time of anesthetic induction, 15 to 30 min before incision. Maintenance 1.5 mg/kg/h until end of care / discharge from the intensive care unit (reduced to 1 mg/kg/h in the post-interventional monitoring room), i.e. between 1 and 2 hours after the end of surgery.
PLACEBO Intravenous electric syringe	rachi morphine anesthesia	Induction bolus 1.5 mg/kg (adjusted weight) intraoperatively, at the time of anesthetic induction, 15 to 30 min before incision. Maintenance 1.5 mg/kg/h until end of care / discharge from the intensive care unit (reduced to 1 mg/kg/h in the post-interventional monitoring room), i.e. between 1 and 2 hours after the end of surgery.
PLACEBO Intravenous electric syringe	laparotomy	Induction bolus 1.5 mg/kg (adjusted weight) intraoperatively, at the time of anesthetic induction, 15 to 30 min before incision. Maintenance 1.5 mg/kg/h until end of care / discharge from the intensive care unit (reduced to 1 mg/kg/h in the post-interventional monitoring room), i.e. between 1 and 2 hours after the end of surgery.
PLACEBO Intravenous electric syringe	Placebo	Induction bolus 1.5 mg/kg (adjusted weight) intraoperatively, at the time of anesthetic induction, 15 to 30 min before incision. Maintenance 1.5 mg/kg/h until end of care / discharge from the intensive care unit (reduced to 1 mg/kg/h in the post-interventional monitoring room), i.e. between 1 and 2 hours after the end of surgery.
PLACEBO Intravenous electric syringe	MORPHINE	Induction bolus 1.5 mg/kg (adjusted weight) intraoperatively, at the time of anesthetic induction, 15 to 30 min before incision. Maintenance 1.5 mg/kg/h until end of care / discharge from the intensive care unit (reduced to 1 mg/kg/h in the post-interventional monitoring room), i.e. between 1 and 2 hours after the end of surgery.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpital Privé Jean Mermoz; 🇫🇷 Lyon, France