Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Digestive System Disease, Surgery
In brief
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.
Key facts
- Study ID
- NCT07076641
- Run by
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- People needed
- 76
- Starts
- 2026-07-01
- Expected to finish
- 2027-07-30
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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 ;
- 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.
Where it is running
- Hôpital Privé Jean Mermoz — Lyon, France
Full record on ClinicalTrials.gov
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