Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001282976
Ethics application status
Approved
Date submitted
13/12/2011
Date registered
14/12/2011
Date last updated
4/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
SNAP trial: Sonographic Nerve-block for Laparoscopic Appendicectomy in Children
Scientific title
SNAP trial: In paediatric laparoscopic appendicectomy does sonographically guided rectus sheath nerve block compared to standard port-site local anaesthetic infiltration reduce post-operative pain at the umbilical port site?
Secondary ID [1] 273602 0
Nil
Universal Trial Number (UTN)
Trial acronym
SNAP trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appendicitis 285397 0
Condition category
Condition code
Surgery 285577 285577 0 0
Other surgery
Anaesthesiology 285578 285578 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After induction of anaesthesia an ultrasound-guided rectus sheath ‘nerve-block’ will be performed by the surgeon or anaesthetist.
Nerve block technique:
Guided by an axially orientated ultrasound image incorporating the lateral edge of the rectus muscle the needle will be inserted in-plane to the ultrasound beam and its tip advanced under visualisation to the posterior extent of the rectus muscle. A hypo-echogenic lentiform swelling between posterior rectus sheath and rectus muscle on injection of a small amount of solution will help confirm correct needle tip position. Half of the solution will be injected at this point. The process will be repeated on the contralateral side.
Local anaesthetic dose:
The volume of solution available for the nerve block will be calculated according to the patient’s body weight up to a maximum of 20ml, to maintain a maximum dose of bupivacaine at or below 2.5mg/kg.
Volume (ml) = Weight (kg) -10
Half the volume will be used for each side.
In addition to the nerve block, 10ml 0.25% bupivacaine with 1:400,000 adrenaline will be available for the surgeon for local infiltration of all port sites.
The nerve block is performed once intraoperatively and not repeated.
Intervention code [1] 283888 0
Treatment: Drugs
Comparator / control treatment
"Rectus sheath nerve block' with placebo - normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 286136 0
The primary endpoint will be the Pain Site Scores for the umbilicus
Timepoint [1] 286136 0
0, 4, 8, 12, 16, 20 and 24 hours after surgery
Secondary outcome [1] 295218 0
Pain on visual analogue scale
Timepoint [1] 295218 0
0, 4, 8, 12 ,16, 20 and 24 hours after surgery
Secondary outcome [2] 295219 0
Post-operative opiate consumption in morphine equivalent daily dosage (MEDD)
Timepoint [2] 295219 0
Up to 24 hours
Secondary outcome [3] 295220 0
Day 10 Post-operative Recovery Questionnaire
Timepoint [3] 295220 0
10 days post-operatively
Secondary outcome [4] 295221 0
PedsQL Pediatric Quality of Life Inventory version 4.0 Child Report, and Parent Report for Children
Timepoint [4] 295221 0
6 weeks post-opearatively

Eligibility
Key inclusion criteria
All children presenting to Starship Children’s Hospital, aged between 8 and 14 years, diagnosed with acute appendicitis requiring urgent laparoscopic appendectomy.
Minimum age
8 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of developmental delay, neuro-muscular impairment, attention-deficit disorder, chronic pain, or psychiatric illness.
Unable to speak and read English
Partially sighted or blind
Previous open abdominal surgery
Presence of any abdominal prostheses such as a gastrostomy or ventriculo-peritoneal shunt
Immuno-suppression
Allergy to morphine
Consent not obtained from both the participating child and one parent or legal guardian

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)
Paediatric surgical registrars or consultants will invite children and their parents / whanau to participate in the trial.
Once recruited and consented, the allocation of each participant to the intervention or control group will be performed by an unblinded circulating theatre nurse just prior to the start of the procedure. This nurse will receive written instructions not to disclose the participant’s group allocation to anybody and will have no involvement in the post-operative care of the patient or in data collection, analysis or reporting.
Randomized study allocations will be placed into 200 totally opaque sequentially numbered envelopes by an independent research assistant who will have no subsequent involvement in this study. The envelopes will be securely sealed and kept in a central location. They will be opened strictly in sequence in the operating room just prior to the start of each procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The generation of random numbers will be facilitated by an independent research assistant. The allocation sequence will be generated using an open source computer-based on-line random number generator, http://www.random.org. All numbers from 1 to 156 (to give 20% redundancy) will be generated in random sequence arranged in 2 columns. Study allocation will be based on these numbers.
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
1/03/2012
Actual
25/06/2012
Date of last participant enrolment
Anticipated
18/06/2013
Actual
18/06/2013
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
130
Accrual to date
Final
130
Recruitment outside Australia
Country [1] 4017 0
New Zealand
State/province [1] 4017 0

Funding & Sponsors
Funding source category [1] 284371 0
Hospital
Name [1] 284371 0
Auckland District Health Board
Country [1] 284371 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland District Health Board
Address
Private Bag 92024
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 283309 0
None
Name [1] 283309 0
Address [1] 283309 0
Country [1] 283309 0
Other collaborator category [1] 260396 0
University
Name [1] 260396 0
University of Auckland Department of Surgery
Address [1] 260396 0
Auckland Clinical School
Level 12
Auckland City Hospital Support Building
Park Road
Grafton
Auckland 1142
Country [1] 260396 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286333 0
Multi-region Ethics Committee
Ethics committee address [1] 286333 0
Ethics committee country [1] 286333 0
New Zealand
Date submitted for ethics approval [1] 286333 0
14/12/2011
Approval date [1] 286333 0
30/01/2012
Ethics approval number [1] 286333 0
MEC/12/01/006

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 627 627 0 0
/AnzctrAttachments/347854-StudyManual.pdf

Contacts
Principal investigator
Name 33532 0
Dr James Hamill
Address 33532 0
Starship Hospital
Private Bag 92024
Auckland 1142
New Zealand
Country 33532 0
New Zealand
Phone 33532 0
+6421753081
Fax 33532 0
Email 33532 0
[email protected]
Contact person for public queries
Name 16779 0
James Hamill
Address 16779 0
Paediatric Surgery & Urology Services
Starship Children's Hospital
Private Bag 92024
Auckland 1142
Country 16779 0
New Zealand
Phone 16779 0
+64 21 753081
Fax 16779 0
Email 16779 0
[email protected]
Contact person for scientific queries
Name 7707 0
James Hamill
Address 7707 0
Paediatric Surgery & Urology Services
Starship Children's Hospital
Private Bag 92024
Auckland 1142
Country 7707 0
New Zealand
Phone 7707 0
+64 21 753081
Fax 7707 0
Email 7707 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.