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

NCT07076641 | Not Yet Recruiting Phase 3

• 1 other identifier: 2025-521206-18-00
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive System Disease; Surgery

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  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.

  2 days

Study Arms (2)

LIDOCAINE Intravenous electric syringe

EXPERIMENTAL

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.

Procedure: rachi morphine anesthesia; Procedure: laparotomy; Drug: Lidocaine IV; Drug: MORPHINE

PLACEBO Intravenous electric syringe

PLACEBO COMPARATOR

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.

Procedure: rachi morphine anesthesia; Procedure: laparotomy; Drug: Placebo; Drug: MORPHINE

Interventions

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.

LIDOCAINE Intravenous electric syringe; PLACEBO Intravenous electric syringe

rachi morphine anesthesia PROCEDURE

Morphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room.

LIDOCAINE Intravenous electric syringe; PLACEBO Intravenous electric syringe

laparotomy PROCEDURE

major digestive or abdominal surgery by laparotomy

LIDOCAINE Intravenous electric syringe; PLACEBO Intravenous electric syringe

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.

LIDOCAINE Intravenous electric syringe

Placebo DRUG

Sodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride.

PLACEBO Intravenous electric syringe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ;

Sponsors & Collaborators

• Euraxi Pharma: collaborator
• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Laparotomy; Morphine

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Florent SIGWALT, MD

CONTACT

688620169; florent.sigwalt@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, interventional, comparative, randomized, 2-group parallel, placebo-controlled, double-blind clinical trial

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 22, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

FR (1)