Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000428561
Ethics application status
Not yet submitted
Date submitted
3/10/2006
Date registered
4/10/2006
Date last updated
4/10/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of 0.25% levobupivacaine with adrenaline following caudal epidural administration in children
Scientific title
Pharmacokinetics of 0.25% levobupivacaine with adrenaline following caudal epidural administration in children
Secondary ID [1] 306 0
Royal Childrens' Hospital Ethics in Human Research Committee (EHRC): Trial Number 26112
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetics in children receiving Levobupivacaine 1400 0
Condition category
Condition code
Other 1492 1492 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adrenaline 1:200000 will be used as an adjuvant with levobupivacaine 0.25% for single shot caudal epidural analgesia in children. Plasma levobupivacaine levels will be assayed at random times in the first six hours following the single caudal injection. Results will be analysed using a population pharmacokinetic model (NONMEM) to assess the impact of adrenaline on plasma levels of levobupivacaine.
Intervention code [1] 1387 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Historical

Outcomes
Primary outcome [1] 2063 0
Plasma levobupivacaine levels following single shot caudal epidural anlagesia with levobupivacaine 0.25% and adrenaline 1:200000.
Timepoint [1] 2063 0
In the six hours following single shot caudal epidural anlagesia with levobupivacaine and adrenaline. Up to three random plasma levobupivacaine levels will be assayed in this time period.
Secondary outcome [1] 3554 0
Pharmacokinetic profile of levobupivacaine over six hours following its use in caudal epidural analgesia with Adrenaline 1:200000. Up to three random plasma measurements taken during this six hours will be analysed via NONMEM population pharmacokinetic modelling to give a population plasma concentration versus time profile, volume of distribution and clearance data.
Timepoint [1] 3554 0

Eligibility
Key inclusion criteria
Children undergoing subumbilical surgery for which caudal analgesia is indicated.
Minimum age
Not stated
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to levobupivacaine, refusal, major renal, hepatic or cardiac disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1630 0
Charities/Societies/Foundations
Name [1] 1630 0
ASA (Austalian Society of Anaesthetists) Abbott Research Grant
Country [1] 1630 0
Australia
Primary sponsor type
Hospital
Name
Royal Childrens' Hospital
Address
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 1433 0
None
Name [1] 1433 0
Nil
Address [1] 1433 0
Country [1] 1433 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3076 0
Royal Children's Hospital
Ethics committee address [1] 3076 0
Flemington ROad Parkville Vic 3052
Ethics committee country [1] 3076 0
Australia
Date submitted for ethics approval [1] 3076 0
Approval date [1] 3076 0
Ethics approval number [1] 3076 0

Summary
Brief summary
Brief Synopsis

Levobupivacaine, the S(-) enantiomer of racemic bupivacaine, has been shown to be less cardiotoxic than racemic bupivacaine and its R(+) enantiomer while retaining equipotent local anaesthetic properties, and is commonly used by paediatric anaesthetists.

The pharmacokinetics of levobupivacaine in children under 2 years of age (1), and of children less than 3 months of age (2) after caudal epidural blockade have been published; pharmacokinetics in children after levobupivacaine administration via lumbar epidural catheter and ilioinguinal nerve block have also been examined (3, 4).

Adrenaline is commonly added to local anaesthetic solutions, both to provide a marker of inadvertent intravascular injection of solution, and with the intention to induce vasoconstriction thereby reducing the rate of systemic absorption of local anaesthetic (resulting in both lower peak plasma levels and therefore potential for toxicity, and longer duration of local anaesthetic effect). The pharmacokinetics of levobupivacaine administered with adrenaline have not been examined.

We propose a study of the pharmacokinetics of levobupivacaine when administered via the caudal epidural route, with the addition of adrenaline. We plan to enroll 50 subjects up to 18 years of age undergoing elective sub-umbilical surgical procedures for which caudal epidural analgesia is indicated. Subjects will receive 2mg/kg levobupivacaine, as a 0.25% solution with adrenaline 5 mcg/mL (1:200 000), via the caudal route, under general anaesthesia. Peripheral venous blood samples will be taken from a dedicated intravenous catheter inserted at the time of surgery. Up to 5 blood samples per subject will be taken in the period up to six hours post caudal injection. Samples will be assayed for plasma levobupivacaine.

Analysis of raw data will use a population, rather than individual, pharmacokinetic model (NONMEM), allowing accurate estimation of population parameters from data taken from a small number of subjects, and allowing inclusion of incomplete sample data from individual subjects (5). Sample timing is not crucial where this form of analysis is used, so proposed sampling times need not be strictly adhered to.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27614 0
Address 27614 0
Country 27614 0
Phone 27614 0
Fax 27614 0
Email 27614 0
Contact person for public queries
Name 10576 0
Dr George Chalkiadis
Address 10576 0
Department of Anaesthesia and Pain Management
Royal Childrens' Hospital
Flemington Road
Parkville VIC 3052
Country 10576 0
Australia
Phone 10576 0
+61 3 93455233
Fax 10576 0
+61 3 93456003
Email 10576 0
[email protected]
Contact person for scientific queries
Name 1504 0
Dr Tamara Culnane
Address 1504 0
Department of Anaesthesia and Pain Management
Royal Childrens' Hospital
Flemington Road
Parkville VIC 3052
Country 1504 0
Australia
Phone 1504 0
+61 3 93455233
Fax 1504 0
+61 3 93456003
Email 1504 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.