Major surgery MedDRA version: 9.1 Level: SOC Classification code 10042613
Conditions
Interventions
Trade Name: NAROPINA
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ropivacaine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
T
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >= 18; ASA I or II; planned for major surgery; no absumption of other oppioid analgesic;no mental abnormal conditions; written informed consent. 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: Emergency surgery; patient recovered in intensive care unit; alteration of coagulation values; absumption of FANS in the previous 5 days; platelets <100.000 mm3; liver or renal failure; allergies to FANS ...
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of plasma concentration and pharmacokinetics of levbupivacaine and ropivacaine during epidural infusion;Secondary Objective: Safety, efficacy and adverse events: differences between the two IMPs;Primary end point(s): Levobupivacaine and ropivacaine ematic concentration after 3, 6, 12, 24, 48, 54 e 60 hours | — |
Countries
Italy
Outcome results
None listed