Evaluation of pharmacokinetics of levobupivacaine and ropivacaine during epidural infusion - ND
- Conditions
- Major surgeryMedDRA version: 9.1Level: SOCClassification code 10042613
- Registration Number
- EUCTR2010-019393-32-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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 ...
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method