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 injections Secondary 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
Conditions
Interventions
Trade Name: Naropin
Product Name: ropivacaine
Pharmaceutical Form: Solution for infusion
Trade Name: chirocaine
Product Name: levobupivacaine
Pharmaceutical Form: Solution for infusion
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: compare the analgesic efficacy of levobupivacaine and ropivacaine in patient-controlled epidural analgesia, as assessed by the number of requests for epidural bolus injections;Secondary Objective: to compare visual analogue scale (VAS) scores and neural block characteristics (level of sensory blockade and degrees of motor block) and hemodynamic data between the three study groups to compare the incidences of side effects, in particular nausea, pruritus, hypotension and sedation ;Primary end point(s): •Number of requests of patient-controlled 2 mL boluses (granted and refused) •Visual analogue scale (100 mm) scores for resting pain at T = 6, 12, 24 and 48 hours •Motor block (0-12) scores for the lower extremities motor blockade at T = 6, 12, 24 and 48 hours •Level of sensory blockade (number of dermatomes) at T = 6, 12, 24, and 48 hours (thermal sensation) •Systolic and diastolic blood pressure, heart rate, mixed venous oxygen saturation by pulse-oximetry and respiratory rate at T = 6, 12, 24,and 48 hours •Time of removal of the epidural catheter •Incidence of nausea, pruritus, hypotension or sedation •Overall patient satisfaction with pain treatment (scale 1-10) | — |
Countries
Netherlands
Outcome results
None listed