Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000575336
Ethics application status
Approved
Date submitted
3/08/2008
Date registered
12/11/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to compare the post operative analgesia and ease of performance following the surgical repair of inguinal hernias and orchidopexy in children
Scientific title
A comparison of ultrasound guided transversus abdominis plane block and ultrasound guided ilioinguinal nerve block for pain relief following paediatric inguinal hernia repair or orchidopexy
Secondary ID [1] 253062 0
Inguinal
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inguinal hernia and orchidopexy surgery requiring anaesthesia. 3489 0
Condition category
Condition code
Anaesthesiology 3644 3644 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound guided transversus abdominis block

Once general anaesthesia has been established the primary investigator, or consultant anaesthetist experienced in ultrasound-guided regional anaesthesia in children, will perform the transversus abdominis nerve block. A Micromaxx ultrasound machine with either a hockey stick or high frequency linear (HFL) probe will be used to identify the relevant structures. Following aseptic preparation of the puncture site and the ultrasound probe, the transversus abdominis nerve block will be performed under cross-sectional continuous ultrasound imaging. A 22g spinal needle will be used. A transversely orientated ultrasound probe with an imaging depth of 4 to 6 cm is placed on the anterolateral abdominal wall where the three muscle layers are most distinct. After identification of the transversus plane between the internal oblique and transversus abdominis muscles, the probe is moved posterolaterally to lie across the mid axillary line just superior to the iliac crest. The needle is introduced anteriorly, in the plane of the ultrasound beam. The probe is moved anteriorly to identify the needle after skin puncture and then moved posteriorly in order to image the needle during its entire passage through the abdominal wall. The needle obliquely approaches the transversus abdominis plane and near perpendicular to the ultrasound beam. The needle tip is guided posterior to the mid axillary line in order to block the lateral nerve branches. Once the needle is correctly positioned a predetermined volume of 1% lignocaine and 1% Ropivacaine will be injected following a negative aspiration test. A total of 0.3ml/kg (to a maximum of 10 ml) of combined 1% lignocaine and 1% ropivacaine will be infiltrated 5 minutes prior to skin incision.
Intervention code [1] 3212 0
Treatment: Devices
Comparator / control treatment
Ultrasound guided ilioinguinal nerve block

Once general anaesthesia has been established the primary investigator, or consultant anaesthetist experienced in ultrasound guided regional anaesthesia in children will perform the ilioinguinal nerve block. A Micromaxx ultrasound machine with either a hockey stick or high frequency linear (HFL) probe will be used to identify the relevant structures. Following aseptic preparation of the puncture site and the ultrasound probe the ilioinguinal nerve block will be performed under cross-sectional continuous ultrasound imaging. A 22g spinal needle will be used. Once the needle is visualised by ultrasound and placed in optimal position relative to the nerves, a single injection of a predetermined volume of 1% lignocaine and 1% ropivacaine will be injected following a negative aspiration test. A total of 0.3 mL/kg (to a maximum of 10 ml) of combined 1% lignocaine and 1% ropivacaine will be infiltrated 5 minutes prior to skin incision.
Control group
Active

Outcomes
Primary outcome [1] 4544 0
Analgesic requirements will be measured as follows;
Intraoperatively: number of fentanyl doses.
In Post Anaesthesia Care Unit (PACU): number of morphine doses.
Post Operatively: Time to first dose of paracetamol and ibuprofen.
Timepoint [1] 4544 0
First 24 hours
Secondary outcome [1] 7693 0
Quality ultrasound images. Images to be graded by principal investigator as vivid/good/satisfactory/poor
Timepoint [1] 7693 0
First 5 min

Eligibility
Key inclusion criteria
Paediatric patients requiring inguinal hernia repair or orchidopexy.
Minimum age
1 Weeks
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patient refusal/inability to consent
2. Allergy amide local anaesthetic (LA) drugs
3. History of seizures or neurological disorders
4. Infection at site of needle puncture
5. Inability to visualise the appropriate structures on ultrasound

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
If the patient is suitable, a patient information leaflet will be sent via mail a week prior to the planned operation date. The participants will be seen as part of the routine preoperative assessment and at this contact, consent for participation will be obtained.
Randomisation will occur by a computer generated random number and delivered in a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
According to the randomisation, the patient will receive either the ultrasound guided ilioinguinal nerve block, or the ultrasound guided transversus abdominis plane block. Randomisation will occur by computerised sequence generation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1096 0
New Zealand
State/province [1] 1096 0
Auckland

Funding & Sponsors
Funding source category [1] 3666 0
Hospital
Name [1] 3666 0
Auckland City Hospital
Anaesthesia Research Trust
Country [1] 3666 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael Fredrickson
Address
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country
New Zealand
Secondary sponsor category [1] 3293 0
None
Name [1] 3293 0
Address [1] 3293 0
Country [1] 3293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5718 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5718 0
P O Box 1031
Waikato Mail Centre
Hamilton 3240
Ethics committee country [1] 5718 0
New Zealand
Date submitted for ethics approval [1] 5718 0
Approval date [1] 5718 0
20/02/2008
Ethics approval number [1] 5718 0
NTY/08/01/010

Summary
Brief summary
The purpose of this study is to compare two methods of regional anaesthesia on analgesia requirements for paediatric patients during and following inguinal hernia repair or orchidopexy, and assess the technical ease of insertion. The outcome measures include the quality of ultrasound images, intraoperative fentanyl dose, postoperative morphine dose, pain scores and time to first dose of paracetamol/ibuprofen.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28796 0
Address 28796 0
Country 28796 0
Phone 28796 0
Fax 28796 0
Email 28796 0
Contact person for public queries
Name 11953 0
Dr Michael Fredrickson
Address 11953 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 11953 0
New Zealand
Phone 11953 0
+64 9 522 1117
Fax 11953 0
+64 9 522 1127
Email 11953 0
[email protected]
Contact person for scientific queries
Name 2881 0
Dr Michael Fredrickson
Address 2881 0
P O Box 109 199
Newmarket
Auckland 1149
Country 2881 0
New Zealand
Phone 2881 0
+64 9 522 1117
Fax 2881 0
+64 9 522 1127
Email 2881 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.