„Levobupivacaine for postoperative pain control in patients with knee arthroplasty – a comparison with ropivacaine
Phase 1
- Conditions
- patients undergoing total knee arthroplasty
- Registration Number
- EUCTR2005-000694-22-DE
- Lead Sponsor
- Prof. Dr.Christian Werner
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria
Patients ASA I to ASA III, aged between 18 and 85 years, who gave written informed consent to a regional anesthetic and who are scheduled for total knee arthroplasty
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
Insufficiency of heart, liver or kidney; SUD; Gravidity; ASA IV; Allergic disposal to local anesthetics; Patient refuses regional technique
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: It is assumed, that levobupivacaine 0.125% compared to ropivacaine 0.2% provides equal analgesic properties when administered continuously via femoral nerve catheter after total knee arthroplasty, thus resulting in a significant decrease of local anesthetic substance consumption (background infusion + PCA demand).<br><br><br>;Secondary Objective: ;Primary end point(s): Primary endpoint: defined as the cumulative volume of local anesthetic within the first 48 postoperative hours (background infusion + PCA demand).<br><br>
- Secondary Outcome Measures
Name Time Method