To determine the best doses-respons of levobupivacaine for postoperatief analgesia after caudal anesthesia for hypospadia repair.
ID
Source
Brief title
Condition
- Urethral disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain will be assessed at predetermined points with the Children and Infants
Postoperative Pain Scale (CHIPPS). At a score > 3 rescue medication will be
administered. Furthermore, the time interval until children are able to move
their legs and stand, will be registered. The observation period is 24 hours.
Secondary outcome
Discharge from hospital
rehospitalisation after discharge due to pain
Background summary
Comparison of three different doses of levobupivacaïne for caudal block in
children undergoing hypospadia repair.
A dubbelblind randomised study
Levobupivaca*ne is less cardiotoxic and therefore has a wider therapeutic range
than Bupivaca*ne, while exhibiting comparable analgetic properties. Still,
there is little data on the dose-effect relationship of Levobupivaca*ne in
children. The aim of this prospective study was to investigate the duration of
analgesia and motor blockade of three different doses of Levobupivaca*ne for a
caudal block in children undergoing hypospadia repair and to determine the
optimum dosis- effect result.
Study objective
To determine the best doses-respons of levobupivacaine for postoperatief
analgesia after caudal anesthesia for hypospadia repair.
Study design
Prospective doubleblind randomized of studydesign.
After standard general anesthesia seventyfive childeren receive caudal
anesthesia for postoperative painrelief. 3 group of 25 patiënten.
Groep A: CA with 0,5ml Levobupivacaine 0,125%/kg bodywight
Groep B: CA with 0,5ml Levobupivacaine 0,250%/kg bodywight
Groep C: CA with 0,5ml Levobupivacaine 0,375%/kg bodywight
Study burden and risks
There will be no risk for our patients. We expect a reduction of risk because
levobupivacaine is less cardiotoxic than bupivacaine. Because the frequency of
painmonitoring we also expect more quality of care.
geert grooteplein 10
6500 hb
Nederland
geert grooteplein 10
6500 hb
Nederland
Listed location countries
Age
Inclusion criteria
childeren in age of 6 month till 4 years, receving hypospadiacorrection. informed consent by the parents
Exclusion criteria
illness or medication influencing the bloodclotting, vasculopathy, thrombopathy, allergic for local anesthetics
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-002291-17-NL |
| CCMO | NL12213.091.06 |