hepatectomy or segmentectomy MedDRA version: 12.1 Level: LLT Classification code 10034067 Term: Partial hepatectomy MedDRA version: 12.1 Level: LLT Classification code 10044087 Term: Total hepatectomy
Conditions
Interventions
Trade Name: NAROPEINE
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Sponsors
CHU Saint-Etienne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • > 18 years • hepactectomy or segmentectomy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Sepsis uncontrolled current • Overdose in anticoagulant during general anesthesia • Thrombocytopenia <50 g / dl • Severe renal impairment: Cockcroft <30 ml / min • history of ventricular arrhythmia serious unexplained .* • Allergy to local anesthetics of the amide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Decreased consumption of morphine over the first 48 hours postoperative.;Secondary Objective: Comparison of functional rehabilitation in 2 groups: - Resumption of passage, food - time to first get up - Released from hospital Evaluation of the incidence of urinary tract infections, pulmonary thromboembolism, pulmonary infections during hospitalization, according to usual clinical practice of the service. -Study of the pharmacokinetics of ropivacaine.;Primary end point(s): Consumption of morphine on the first 48 hours postoperative | — |
Countries
France
Outcome results
None listed