ANZCTR - Registration

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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]

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

Condition category

Condition code

Other

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]

Treatment: Drugs

Comparator / control treatment

No comparator.

Control group

Historical

Outcomes

Primary outcome [1]

Plasma levobupivacaine levels following single shot caudal epidural anlagesia with levobupivacaine 0.25% and adrenaline 1:200000.

Timepoint [1]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

ASA (Austalian Society of Anaesthetists) Abbott Research Grant

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Childrens' Hospital

Address

Parkville VIC 3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Royal Children's Hospital

Ethics committee address [1]

Flemington ROad Parkville Vic 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr George Chalkiadis

Address

Department of Anaesthesia and Pain Management
Royal Childrens' Hospital
Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 93455233

Fax

+61 3 93456003

george.chalkiadis@rch.org.au

Contact person for scientific queries

Name

Dr Tamara Culnane

Address

Department of Anaesthesia and Pain Management
Royal Childrens' Hospital
Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 93455233

Fax

+61 3 93456003

tamara.culnane@rch.org.au

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.

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