A randomised, double-blind, prospective study to compare the analgesic efficacy of 10 ml epidural loading dose levobupivacaine 0.5% versus levobupivacaine 0.25% in patients after major abdominal or thoracic surgery.
Phase 1
- Conditions
- patient controlled epidural pain therapy after major abdominal or thoracic surgery
- Registration Number
- EUCTR2007-000700-32-BE
- Lead Sponsor
- niversity hospitals Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
abdominal or thoracic surgery with the necessity of a PCEA-system
ASA 1,2,3
age of 18 or older
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
coagulation problems
chronic pain patient
allergy to local anesthetics
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To record the incidence of a perfect sensoric block after the administration of a epidural loading dose of 10 ml levobupivacaine 0.5% compared with 10ml levobupivacaine 0.25%;Secondary Objective: Evaluation of the hemo-dynamic stability first 3 hours after the administration of the loading dose.<br>To record the incidence of adverse events.;Primary end point(s): Has the epidural administration of 10ml levobupivacaine 0.5% a better analgesic effect compared with 10ml levobupivacaine 0.25% ?
- Secondary Outcome Measures
Name Time Method