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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rachi morphine anesthesia | Procedure | Morphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florent SIGWALT, MD | Contact | 688620169 | +33 | florent.sigwalt@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Jean Mermoz | Lyon | 69008 | France |
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Prospective, interventional, comparative, randomized, 2-group parallel, placebo-controlled, double-blind clinical trial
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double-blind
| laparotomy | Procedure | major digestive or abdominal surgery by laparotomy |
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| 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. |
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| Placebo | Drug | Sodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride. |
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| 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. |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007813 | Laparotomy |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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