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Trial registered on ANZCTR


Registration number
ACTRN12608000314325
Ethics application status
Approved
Date submitted
12/06/2008
Date registered
1/07/2008
Date last updated
15/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The analgesic efficacy of ultrasound guided transversus abdominis plane (TAP) block after laparascopic appendicectomy in children: a prospective randomised trial
Scientific title
The analgesic efficacy of ultrasound guided transversus abdominis plane (TAP) block after laparascopic appendicectomy in children: a prospective randomised trial
Secondary ID [1] 588 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain after laparscopic appendicectomy 3257 0
Condition category
Condition code
Anaesthesiology 3422 3422 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive a standardised general anaesthetic. This will involve a rapid sequence induction with propofol (3 mg/kg) by an intravenous injection and suxamethonium (1.5-2 mg/kg) by an intravenous injection and continued paralysis with atracurium (initially 0.5 mg/kg intravenous followed by 0.2 mg/kg intravenous at approximately 30 minute intervals). Anaesthesia will be further maintained with nitrous oxide 70 % in O2 and sevoflurane (titrated to effect). All patients will receive intravenous (IV) fentanyl (1 mcg/kg) at the commencement of surgery and ondansetron (200 mcg/kg) to a maximum of 4 mg IV towards the end of the procedure. Standard monitoring including electrocardiogram, non-invasive arterial blood pressure, arterial oxygen saturation and end tidal carbon dioxide monitoring will be used throughout. The surgical technique will also be standardised. All patients will have laparoscopy port sites infiltrated by the surgeons as per routine practice with 0.5 ml/kg of 0.2% Ropivacaine (1 mg/kg total ropivacaine).

Technique for Ultrasound guided TAP block.
Laparascopic appendicectomy requires that the TAP block be placed bilaterally. A 38 mm linear array Ultrasound probe transducer (Sonosite Micromaxx (Registered) SonoSite, Inc. 21919 30th Drive SE Bothell, WA) is placed in either flank with the probe orientated on a line joining the umbilicus and the 3rd / 4th lumbar vertebrae. A needle is advanced under aseptic conditions from an injection point on the antero-lateral abdominal wall, at about the level of the umbilicus, in the plane of the ultrasound. The needle is advanced until the tip lies between the transversus abdominus and the internal oblique muscles. A total of 1 ml/kg of 0.2% ropivacaine (2 mg/kg total ropivacaine) is drawn up. Half of this volume is injected on the left hand side and the other half on the Right hand side. A remaining 0.5 ml/kg or 0.2 % ropivacaine (1 mg/kg total ropivacaine) will be available to the surgeons for infiltration of port sites.

Total dose of ropivacaine will be restricted to 3 mg / kg in according with published dose recommendations.


Post-operatively each patient will be prescribed intravenous Patient Controlled analgesia with morphine as per the Sydney Children’s Hospital protocol and regular paracetamol 15 mg/kg Per Orum every 4 hours. The Sydney Children's Hospital protocol is to draw up 750 microg / kg of morphine into a 50 ml syringe and dilute to 50 ml with normal saline. The patient will be prescribed 1 ml intravenous boluses as required with a machine lockout period of 5 minutes. This will mean that each bolus of intravenous morphine will be 15 microg/kg. There must be no background infusion on the Patient controlled analgesia (PCA). No other analgesics are to be prescribed during the first 16 hours post-operatively unless commenced by the Acute Pain Service. Patients must also be prescribed post-operatively ondansetron 200 microg/kg intravenous (to a maximum of 4 mg) every 8 hours when necessary.
Intervention code [1] 2997 0
Treatment: Other
Comparator / control treatment
Standard care (Standard General anaesthesia with no TAP block). No placebo
Control group
Active

Outcomes
Primary outcome [1] 4362 0
Primary outcome: Reduced PCA morphine consumption in the first 16 hours from the completion of anaesthesia.
Timepoint [1] 4362 0
First 16 hours post-operative. PCA morphine consumption will be considered for both the first 8 hours from the completion of anaesthesia, the second 8 hours and the total morphine consumption in the firsts 16 hours from the completion of anaesthesia
Secondary outcome [1] 7346 0
Increased time to first supplemental analgesia from the completion of anaesthesia
Timepoint [1] 7346 0
Time at which any form of analgesia is administered after the completion of anaesthesia
Secondary outcome [2] 7347 0
Reduced PCA morphine consumption in the first 8 hours after the completion of anaesthesia
Timepoint [2] 7347 0
Completion of anaesthesia to 8 hours after the end of anaesthesia
Secondary outcome [3] 7348 0
Reduced morphine PCA consumption from 8 hours after the completion of anaesthesia to 16 hours after the completion of anaesthesia
Timepoint [3] 7348 0
8 hours from completion of anaesthesia to 16 hours after the completion of anaesthesia
Secondary outcome [4] 7350 0
Increased time from the completion of anaesthesia to the first dose of PCA morphine
Timepoint [4] 7350 0
Time of first PCA button push
Secondary outcome [5] 7351 0
Reduced Pain measured by Visual analogue scale at 6 to 8 hours after the completion of anaesthesia
Timepoint [5] 7351 0
VAS at 6 to 8 hours after the completion of anaesthesia
Secondary outcome [6] 7352 0
Reduced Pain measured by Visual analogue scale at 10 to 12 hours after the completion of anaesthesia
Timepoint [6] 7352 0
VAS at 10 to 12 hours after the completion of anaesthesia
Secondary outcome [7] 7353 0
Reduced time to Hospital discharge
Timepoint [7] 7353 0
Time from completion of anaesthesia to time of discharge from hospital
Secondary outcome [8] 7354 0
Reduced Pain in the recovery ward measured by VAS at the time of recovery ward discharge
Timepoint [8] 7354 0
Time of recovery ward discharge
Secondary outcome [9] 7355 0
Reduced sedation scores at the time of recovery ward discharge
Timepoint [9] 7355 0
Time of recovery ward discharge
Secondary outcome [10] 7356 0
Reduced Postoperative vomiting and nausea measured by number of antiemtic administrations in the first 16 hours following completion of anaesthesia
Timepoint [10] 7356 0
From completion of anaesthesia to 16 hours after the completion of anaesthesia

Eligibility
Key inclusion criteria
Any consented patient aged 7-16 years who is scheduled for laparoscopic appendicectomy.
Minimum age
7 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The study exclusion criteria will include intolerance to morphine, unavailability of a Approved Healthcare interpreter in patients with a poor grasp of English, an inability to use a PCA device or the need to convert from laparascopic to open procedure.

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)
Consent as per the inclusion and exclusion criteria and allocated by independent investigator: Participants will be enrolled into the study and then randomised using a central computer generated sequence. The randomisation code will be generated and kept by an identified randomisation officer who will be contacted prior to each individual case by the procedural anaesthetist in order to provide an instruction concerning allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved using an online, computer generated sequence (http://www.randomizer.org/index.htm).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Bandaids placed on injection and potential injection points for both arms of the study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/06/2008
Actual
18/07/2008
Date of last participant enrolment
Anticipated
Actual
16/12/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3478 0
Hospital
Name [1] 3478 0
Sydney Children's Hospital Department of Anaesthesia
Country [1] 3478 0
Australia
Primary sponsor type
Individual
Name
Dr David Sandeman
Address
Department of Anaesthesia, Sydney Children's Hospital, High St Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 3121 0
None
Name [1] 3121 0
Address [1] 3121 0
Country [1] 3121 0
Other collaborator category [1] 310 0
Individual
Name [1] 310 0
Dr Anthony Dilley
Address [1] 310 0
Dept Surgery: Sydney Children's Hospital, High St Randwick NSW 2031
Country [1] 310 0
Australia
Other collaborator category [2] 311 0
Individual
Name [2] 311 0
Dr Adam Perzcuk
Address [2] 311 0
Dept Anaesthesia, Sydney Children's Hospital, Avoca St Randwick NSW 2031
Country [2] 311 0
Australia
Other collaborator category [3] 277650 0
Individual
Name [3] 277650 0
Assoc Prof Michael Bennett
Address [3] 277650 0
Department of Hyperbaric Medicine
Prince Of Wales Hospital
Randwick NSW 2034
Country [3] 277650 0
Australia
Other collaborator category [4] 277651 0
Individual
Name [4] 277651 0
Dr Siv Ein Lim
Address [4] 277651 0
Department of Anaesthesia
Prince Of Wales Hospital
Randwick NSW 2034
Country [4] 277651 0
Australia
Other collaborator category [5] 277652 0
Individual
Name [5] 277652 0
Dr Keith Kelly
Address [5] 277652 0
Department of Anaesthesia
Prince of Wales Hospital
Randwick NSW 2034
Country [5] 277652 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5508 0
South Eastern Sydney and Illawarra Area Health service Northern Sector
Ethics committee address [1] 5508 0
Prince of Wales Hospital, High St Randwick NSW 2031 Australia (phone 9382 3587, fax 9382 2813
Ethics committee country [1] 5508 0
Australia
Date submitted for ethics approval [1] 5508 0
18/12/2007
Approval date [1] 5508 0
11/06/2008
Ethics approval number [1] 5508 0
08/002

Summary
Brief summary
Safe and effective regional anaesthesia requires local anaesthetics to be placed in close proximity to nerves without injury to the target nerves or adjacent structures. A promising approach to the provision of postoperative analgesia after abdominal surgery is to block the sensory nerve supply to the anterior abdominal wall. Ultrasound guidance allows accurate identification of target tissue planes whilst avoiding adjacent structures. Ultrasound guidance also allows spread of local anaesthetic to be monitored in real time during the injection. We therefore anticipate improved safety and efficacy when utilising ultrasound guided TAP block when compared to standard care.

Standard care for laparascopic appendicectomy involves general anaesthesia and endotracheal intubation, intravenous opiate and local anaesthetic infiltration of laparascopic port sites by the surgeon. In this study we will add to standard care bilateral ultrasound guided TAP block.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28665 0
Dr Dr David Sandeman
Address 28665 0
Department of Anaesthesia
Sydney Children's Hospital
High St
Randwick NSW 2031
Australia
Country 28665 0
Australia
Phone 28665 0
0416161046
Fax 28665 0
Email 28665 0
[email protected]
Contact person for public queries
Name 11822 0
Dr Dr David Sandeman
Address 11822 0
49 Oxley St Matraville NSW
Country 11822 0
Australia
Phone 11822 0
0416161046
Fax 11822 0
0296611203
Email 11822 0
[email protected]
Contact person for scientific queries
Name 2750 0
Dr Dr David Sandeman
Address 2750 0
29 Oxley St Matraville 2036 NSW
Country 2750 0
Australia
Phone 2750 0
0416161046
Fax 2750 0
0296611203
Email 2750 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.