Digestive System DiseasePhase 3LIDORACHINCT07076641
Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia
A Phase 3 study testing rachi morphine anesthesia, laparotomy and Lidocaine IV in people with Digestive System Disease and Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive System Disease, Surgery
- What is being tested?
- rachi morphine anesthesia, laparotomy and Lidocaine IV
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to 30 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Privé Jean Mermoz
Lyon, 69008
Florent SIGWALT, MD, florent.sigwalt@gmail.com
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Digestive System Disease, Surgery
- Being tested
- rachi morphine anesthesia, laparotomy, Lidocaine IV, Placebo, MORPHINE
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rachi morphine anesthesiaProcedure or surgery
Morphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room.
laparotomyProcedure or surgery
major digestive or abdominal surgery by laparotomy
Lidocaine IVDrug
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.
PlaceboDrug
Sodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride.
MORPHINEDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: rachi morphine anesthesia; Procedure: laparotomy; Drug: Placebo; Drug: MORPHINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study startSep 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseaseStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, interventional, comparative, randomized, 2-group parallel, placebo-controlled, double-blind clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076641
- Sponsor's protocol ID
- 2025-521206-18-00
- Other IDs
- 2025
- Acronym
- LIDORACHI
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07076641
- Acronym / sponsor ID
- LIDORACHI / 2025-521206-18-00
- Conditions
- Digestive System Disease, Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, interventional, comparative, randomized, 2-group parallel, placebo-controlled, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| LIDOCAINE Intravenous electric syringe | Experimental | Procedure: rachi morphine anesthesia, Procedure: laparotomy, Drug: Lidocaine IV, Drug: MORPHINEInduction 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 comparator | Procedure: rachi morphine anesthesia, Procedure: laparotomy, Drug: Placebo, Drug: MORPHINEInduction 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rachi morphine anesthesiaMorphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room. | Procedure or surgery | LIDOCAINE Intravenous electric syringe, PLACEBO Intravenous electric syringe |
| laparotomymajor digestive or abdominal surgery by laparotomy | Procedure or surgery | LIDOCAINE Intravenous electric syringe, PLACEBO Intravenous electric syringe |
| Lidocaine IVKABI 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. | Drug | LIDOCAINE Intravenous electric syringe |
| PlaceboSodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride. | Drug | PLACEBO Intravenous electric syringe |
| MORPHINEThe 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. | Drug | LIDOCAINE Intravenous electric syringe, PLACEBO Intravenous electric syringe |
Primary outcome
Total morphine consumption
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rachi morphine anesthesia, laparotomy and Lidocaine IV in people with Digestive System Disease and Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florent SIGWALT, MD (688620169 ext. +33, florent.sigwalt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.