to compare the analgesic efficacy of levobupivacaine and ropivacaine in patient-controlled epidural analgesia, as assessed by the number of requests for epidural bolus injectionsto compare visual analogue scale (VAS) scores and neural block…
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
*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)
Secondary outcome
none
Background summary
In a recently completed study (protocol nr. P04.038) we compared the efficacy
of ropivacaine 0.2 %, ropivacaine 0.125 % and levobupivacaine 0.125 %, all in
combination with sufentanil 1 *g / mL, in terms of epidural pain relief after
total knee replacement (21). Under the conditions of this study we found that
sufentanil was the primary determinant of postoperative pain relief and that
increasing the concentration of local anesthetic (0.2 % versus 0.125 %)
increased the consumption of local anesthetic without increasing the intensity
of pain relief
Study 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
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
Study design
It is a randomisend, prospective and double blinded study
Intervention
epidural analgesia with levobupivacaine 0,125% or ropivacaine 0, 125% or
ropivacaine 0,2% all in combination with sufentanil 0,5 microgram/ml.
Study burden and risks
During the study period there will be four times a short interview and
neurological investigation. Time taken will be 10 minutes each.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
*Female patient >18 years
*ASA class I-III
*Patients undergoing abdominal hysterectomy under combined epidural and general anesthesia
*Written informed consent
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
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-000202-75-NL |
| CCMO | NL16230.058.07 |