|- candidate number||5287|
|- NTR Number||NTR1669|
|- ISRCTN||ISRCTRN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-feb-2009|
|- Secondary IDs||P03.1389C/04/068 CCMO/UMC St Radboud AMO|
|- Public Title||Comparison of different doses of levobupivacain for caudal block in children undergoing hypospadia repair.|
|- Scientific Title||Levobupivacain for paediatric caudal analgesia: Comparison of two different doses of levobupivacaine for caudal block in children undergoing hypospadia repair.|
|- Healt Condition(s) or Problem(s) studied||Hypospadia|
|- Inclusion criteria||Children between the age of six month and four years undergoing hypospadia repair.|
|- Exclusion criteria||Severe co-morbidity: ASA 3 & 4.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-mrt-2005|
|- planned closingdate||1-okt-2005|
|- Target number of participants||20|
|- Interventions||1. Group 0:0.5 ml/kg levobupivacaine 0.125% caudally;|
2. Group 1: 0.5 ml/kg levobupivacaine 0.375% caudally
before surgery commenced.
|- Primary outcome||Duration of analgesia.|
|- Secondary outcome||Motorfunction.|
|- Timepoints||Observation period: until hospital discharge on the first post-op day.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. K.C. Thies|
|- CONTACT for SCIENTIFIC QUERIES||Dr. K.C. Thies|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background: |
Despite the increasing use of Levobupivacain in children there are currently no data available on the duration and quality of caudal analgesia in a homogenous paediatric patient group undergoing a hypospadia repair.
Goal of the study:
To assess the design of a dose-effect of study of Levobupivacain for caudal analgesia and to obtain preliminary data for a power analysis in children undergoing hypospadia repair.
Twenty patients median age 17 months, median weight 10.5 kg were allocated to two groups receiving either 0.5 ml/kg Levobupivavcain 0.125% (Group 0) or 0.5ml/kg Levobupivacain 0.375% (Group 1) caudally for hypospadia repair after induction of anaesthesia with sevoflurane and rocuronium. No further analgesia was given before, during or after the procedure. Pain scores (CHIPPS) were recorded throughout the observation period, which lasted from the start of the procedure until hospital discharge on the following day.
Group 0: six out of ten patients remained pain free throughout the observation period.
Group 1: six out of seven patients remained pain free throughout the observation period.
Both concentrations of Levobupivcaine provided excellent analgesia throughout surgery. The study design is feasible, but given the surprisingly long lasting analgesia we have found in both groups, the observation period needs to be extended.
The duration of analgesia after caudal block with Levobupivacaine was found to be significantly longer lasting than previously reported.
|- Main changes (audit trail)|
|- RECORD||9-feb-2009 - 14-sep-2009|