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Trial registered on ANZCTR


Registration number
ACTRN12608000488303
Ethics application status
Approved
Date submitted
3/08/2008
Date registered
30/09/2008
Date last updated
5/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of ultrasound guided placement of local anaesthetic in the abdominal muscle and local anaesthetic under the skin for pain relief during and following surgical repair of belly button hernias in children
Scientific title
A comparison of ultrasound-guided rectus sheath block and subcutaneous local anaesthetic infiltration for pain relief following paediatric umbilical hernia repair
Secondary ID [1] 259930 0
Umbilical
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Umbilical hernia surgery requiring anaesthesia 3438 0
Condition category
Condition code
Anaesthesiology 3592 3592 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anaesthesia and intraoperative management
General anaesthesia will be induced with 1-8% sevoflurane via a facemask. Anaesthesia will be maintained with 1 minimum alveolar concentration (MAC) sevoflurane. Intraoperative monitoring will include pulse oximetry, non-invasive blood pressure, electrocardiogram (ECG), end tidal carbon dioxide concentration and heart rate. An intraoperative increase in respiratory rate, heart rate or mean arterial pressure of >20% following skin incision or during surgery will be defined as insufficient analgesia and treated with 0.25 ug/kg fentanyl intravenously.


Local wound infiltration
Once general anaesthesia has been established the surgeon will perform all subcutaneous periumbilical local anaesthetic infiltrations. Following aseptic preparation of the site a total of 0.3ml/kg (to a maximum of 5ml) of combined 1% lignocaine and 1% ropivacaine will be infiltrated 5 minutes prior to skin incision.

Ultrasound guided Rectus sheath blocks
Once general anaesthesia has been established the primary investigator, or consultant anaesthetist experienced in ultrasound-guided regional anaesthesia in children, will perform the bilateral rectus sheath block. A Micromaxx ultrasound machine with either a hockey stick or high frequency linear (HFL) probe will be used to identify the relevant structures within the rectus sheath. Following aseptic preparation of the puncture site and the ultrasound probe, the rectus sheath block will be performed under cross-sectional continuous ultrasound imaging. A 22g spinal needle will be used to facilitate placement on both sides of the umbilicus. The injection site will be defined where the optimal ultrasonic visualisation of the posterior sheath is achieved. Once the needle is correctly positioned within the rectus sheath 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 5ml) of combined 1% lignocaine and 1% ropivacaine will infiltrated bilaterally 5 minutes prior to skin incision.
Intervention code [1] 3171 0
Treatment: Devices
Comparator / control treatment
Local wound infiltration

Anaesthesia and intraoperative management

General anaesthesia will be induced with 1-8% sevoflurane via a facemask. Anaesthesia will be maintained with 1 MAC sevoflurane. Intraoperative monitoring will include pulse oximetry, non-invasive blood pressure, ECG, end tidal carbon dioxide concentration and heart rate. An intraoperative increase in respiratory rate, heart rate or mean arterial pressure of >20% following skin incision or during surgery will be defined as insufficient analgesia and treated with 0.25 ug/kg fentanyl intravenously.
Once general anaesthesia has been established the surgeon will perform all subcutaneous periumbilical local anaesthetic infiltrations. Following aseptic preparation of the site a total of 0.3ml/kg (to a maximum of 5ml) of combined 1% lignocaine and 1.0% ropivacaine will be infiltrated 5 minutes prior to skin incision.
Control group
Active

Outcomes
Primary outcome [1] 4554 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] 4554 0
First 24 hours
Secondary outcome [1] 7704 0
Analgesic requirements measured by the number of fentanyl boluses required intraoperatively.
Timepoint [1] 7704 0
First 30 mins

Eligibility
Key inclusion criteria
Paediatric patients requiring umbilical hernia repair
Minimum age
1 Weeks
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient refusal / inability to obtain consent.
2. Allergy amide LA drugs
3. History of seizures or neurological disorders
4. Infection at site of needle puncture
5. Inability to visualise posterior rectus sheath 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 booklet will be sent via mail 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.
Before induction of anaesthesia children will be randomised to 1 of 2 groups. Randomisation will occur by a random number generator and delivered in a sealed opaque envelope. According to the randomisation the patient will receive either subcutaneous local wound infiltration or ultrasound guided bilateral rectus sheath block.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur by a random number generator computer program and will be delivered in a sealed opaque envelope. According to the randomisation the patient will receive either subcutaneous local wound infiltration or ultrasound guided bilateral rectus sheath block.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1048 0
New Zealand
State/province [1] 1048 0

Funding & Sponsors
Funding source category [1] 3622 0
Hospital
Name [1] 3622 0
Anaesthesia Research Trust
Address [1] 3622 0
Park Road
Grafton
Auckland 1023
Country [1] 3622 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] 3257 0
None
Name [1] 3257 0
Address [1] 3257 0
Country [1] 3257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5674 0
Northern X Regional Ethics Committee
Ethics committee address [1] 5674 0
Private Bay 92 522
Wellesley Street
Auckland
Ethics committee country [1] 5674 0
New Zealand
Date submitted for ethics approval [1] 5674 0
Approval date [1] 5674 0
18/02/2008
Ethics approval number [1] 5674 0
NTX/07/12/129

Summary
Brief summary
If the primary hypothesis is confirmed, this study will provide evidence supporting ultrasound placement of bilateral rectus sheath nerve blocks. At present subcutaneous periumbilical local infiltration is the community standard. No study has compared the two techniques to assess which method is more effective for providing analgesia for umbilical hernia repair in paediatric patients. The results of this study may show that ultrasound guided rectus sheath block provides more effective analgesia resulting in patients having decreased analgesic requirements following the periumbilical hernia repair.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28768 0
Address 28768 0
Country 28768 0
Phone 28768 0
Fax 28768 0
Email 28768 0
Contact person for public queries
Name 11925 0
Dr Michael Fredrickson
Address 11925 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 11925 0
New Zealand
Phone 11925 0
0064 9 522 1117
Fax 11925 0
0064 9 522 1127
Email 11925 0
aiservice@xtra.co.nz
Contact person for scientific queries
Name 2853 0
Dr Michael Fredrickson
Address 2853 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 2853 0
New Zealand
Phone 2853 0
0064 9 522 1117
Fax 2853 0
0064 9 522 1127
Email 2853 0
aiservice@xtra.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary