Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000595718
Ethics application status
Approved
Date submitted
21/05/2013
Date registered
27/05/2013
Date last updated
27/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
ultrasound guided transversus abdominis plane block versus local wound infiltration for post-operative analgesia in children undergoing appendectomy: A Randomized Controlled Trial
Scientific title
ultrasound guided transversus abdominis plane block versus local wound infiltration for post-operative analgesia in children undergoing appendectomy: A Randomized Controlled Trial
Secondary ID [1] 282537 0
NIL
Universal Trial Number (UTN)
U1111-1143-3140
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain following appendectomy in children 289204 0
Condition category
Condition code
Anaesthesiology 289533 289533 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a prospective,randomized comparison of 2 patient groups. One group of patients will receive an ultrasound guided transversus abdominis plane (TAP) block at the end of the surgery using 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
Intervention code [1] 287203 0
Treatment: Drugs
Comparator / control treatment
The second group will receive local anesthetic infiltration using 0.4 ml/kg of bupivacaine 0.25% by the surgeon at the end of surgery for a laparoscopic appendectomy.
Control group
Active

Outcomes
Primary outcome [1] 289629 0
Requirement for morphine post-surgery
Timepoint [1] 289629 0
24 hours
Secondary outcome [1] 302890 0
Assessment of pain scores post-surgery using Visual analogue scale
Timepoint [1] 302890 0
24 hours

Eligibility
Key inclusion criteria
- American Society of Anesthesiologists (ASA) classification score 1-2
- Age :4 year to14years
-Weight less than or equal to 60 kg
-Presenting for laparoscopic appendectomy
Minimum age
4 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- ASA physical status > II
- Patients < 4 years of age
- Weight greater than 60 kg
- Co-morbid diseases (cardiac, pulmonary (not including asthma), neurological disease.
- children undergoing an additional surgical procedure at an anatomical location not covered by a unilateral TAP block during the same anesthetic

- children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection

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)
Children aged between 4and 14 years, ASA grade I to II, scheduled for appendectomy, in a randomized, blind,
controlled clinical trial. Patients will be randomly allocated into 2 groups:
One group of patients will receive an ultrasound guided transversus abdominis plane (TAP) block using 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
. The second group will receive local anesthetic infiltration by the surgeon at the end of surgery

. The allocation sequence will be generated by a random number table, and group allocation will be concealed in sealed, opaque envelopes, which will not opened until patient consent obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization will be done using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size was determined After post-hoc power analysis of the time to first analgesic, with power 0.95, effect size 2.3, and alpha equal to 0.05, 18 participants per group were required. This was rounded upwards to 20.

Data will be statistically described in terms of mean +-standard deviation , or frequencies (number of cases) and percentages when appropriate. Data will be tested for normality using Kolmogorov Smirnov test. Comparison between the two study groups will bedone using Student t test for independent samples. p values less than 0.05 will be considered statistically significant. All statistical calculations will be done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 15 for Microsoft Windows

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
Date of last participant enrolment
Anticipated
1/07/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5095 0
Egypt
State/province [1] 5095 0

Funding & Sponsors
Funding source category [1] 287319 0
Self funded/Unfunded
Name [1] 287319 0
Ahmad Ramzy Shaaban
Country [1] 287319 0
Saudi Arabia
Primary sponsor type
Individual
Name
Ahmad Ramzy
Address
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22
Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 286067 0
None
Name [1] 286067 0
Address [1] 286067 0
Country [1] 286067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289291 0
Ain Shams university, Faculty of medicine
Ethics committee address [1] 289291 0
pobox 11566, Abbasya Square 11566, Cairo, Egypt
Ethics committee country [1] 289291 0
Egypt
Date submitted for ethics approval [1] 289291 0
Approval date [1] 289291 0
Ethics approval number [1] 289291 0

Summary
Brief summary
Appendectomy is one of the most frequently performed
surgical procedures in children and is associated
with significant postoperative discomfort and
pain.Multimodal approaches to the provision of postoperative
analgesia often incorporate blockade of the abdominal
wall, such as ilioinguinal blockade or wound infiltration. However,
the efficacy of these approaches is unclear.
This study is a prospective,randomized comparison of 2 patient groups. One group of patients will receive an ultrasound guided transversus abdominis plane (TAP) block using 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
. The second group will receive local anesthetic infiltration by the surgeon at the end of surgery for a laparoscopic appendectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40210 0
Dr AHMAD RAMZY SHAABAN
Address 40210 0
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22 Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia.
Country 40210 0
Saudi Arabia
Phone 40210 0
+966534409797
Fax 40210 0
Email 40210 0
[email protected]
Contact person for public queries
Name 40211 0
Dr AHMAD RAMZY
Address 40211 0
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22 Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia.
Country 40211 0
Saudi Arabia
Phone 40211 0
+966534409797
Fax 40211 0
Email 40211 0
[email protected]
Contact person for scientific queries
Name 40212 0
Dr Ahmad Ramzy
Address 40212 0
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22 Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia.
Country 40212 0
Saudi Arabia
Phone 40212 0
+966534409797
Fax 40212 0
Email 40212 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
SourceTitleYear of PublicationDOI
EmbaseUltrasound guided transversus abdominis plane block versus local wound infiltration in children undergoing appendectomy: A randomized controlled trial.2014https://dx.doi.org/10.1016/j.egja.2014.06.005
N.B. These documents automatically identified may not have been verified by the study sponsor.