A comparison of the efficacy of levobupivacaine 0,125%, ropivacaine 0,125% and ropivacaine 0,2%, all combined with sufentanil 0.5 micrograms/mL, in patient-controlled epidural analgesia after hysterectomy under combined epidural and general anesthesia
- Conditions
- Primary Objective•to compare the analgesic efficacy of levobupivacaine and ropivacaine in patient-controlled epidural analgesia, as assessed by the number of requests for epidural bolus injectionsSecondary Objectives•to compare visual analogue scale (VAS) scores and neural block characteristics and hemodynamic data between the three study groups•to compare the incidences of side effects, in particular nausea, pruritus, hypotension and sedation
- Registration Number
- EUCTR2007-000202-75-NL
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 63
•Female patient > 18 years
•ASA class I-III
•Patients undergoing abdominal hysterectomy under combined epidural and general anesthesia
•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
•Participation in a trial on investigational drugs within 3 months prior to the study
•Known hypersensitivity to amide-type local anesthetics
•Known hypersensitivity to opioids
•Known history of severe cardiovascular, hepatic, renal, respiratory, endocrinological, haematological, neurological or psychiatric disease as judged by the investigator
•Known history of peripheral neuropathies
•Those receiving chronic analgesic therapy
•Any contraindication for epidural analgesia (e.g. clotting disorders, history of lumbar surgery)
•Inability to perform VAS score
•Pregnancy or lactation
•Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method