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

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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07076641

Acronym

LIDORACHI

Enrollment

Registered

2025-07-22

Start date

2026-09-01

Completion date

2027-07-30

Last updated

2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Disease, Surgery

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.

Interventions

PROCEDURErachi morphine anesthesia

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

PROCEDURElaparotomy

major digestive or abdominal surgery by laparotomy

DRUGLidocaine 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.

DRUGPlacebo

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

DRUGMORPHINE

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

double-blind

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Contacts

CONTACTFlorent SIGWALT, MD

florent.sigwalt@gmail.com688620169

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026