N/A
ID
Bron
Verkorte titel
Aandoening
Caudal analgesia, hypospadia, levobupivacaine
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Duration of analgesia.
Achtergrond van het onderzoek
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.
Method:
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.
Results:
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.
Discussion:
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.
Conclusion:
The duration of analgesia after caudal block with Levobupivacaine was found to be significantly longer lasting than previously reported.
Doel van het onderzoek
N/A
Onderzoeksopzet
Observation period: until hospital discharge on the first post-op day.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Children between the age of six month and four years undergoing hypospadia repair.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Severe co-morbidity: ASA 3 & 4.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL1589 |
NTR-old | NTR1669 |
Ander register | CCMO/UMC St Radboud AMO : P03.1389C/04/068 |
ISRCTN | ISRCTRN wordt niet meer aangevraagd |