Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000585921
Ethics application status
Approved
Date submitted
2/06/2011
Date registered
7/06/2011
Date last updated
14/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound-Guided Transversus Abdominis Plane Block in Pediatric Patients: A Randomized Controlled Study
Scientific title
The analgesic efficacy of the ultrasound-guided transversus abdominis plane block with high volume local anesthetic during the first 24 hours after surgery in pediatric patients undergoing inguinal hernia repair.
Secondary ID [1] 262303 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inguinal hernia in pediatrics 268012 0
postoperative analgesia 268013 0
Condition category
Condition code
Anaesthesiology 268143 268143 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For postoperative analgesia ultrasound guided unilateral transversus abdominis plane block was applied with 0.5 mL/kg 0.25 % levobupivacaine just before surgical incision for inguinal hernia repair only one time.
Intervention code [1] 266696 0
Treatment: Drugs
Comparator / control treatment
Infiltration anesthesia with 0.2 mL/kg 0.25 % levobupivacaine for postoperative analgesia just after unilateral inguinal hernia repair
Control group
Active

Outcomes
Primary outcome [1] 266891 0
First analgesic requirement time by using clinical assessments including pain scoring system
Timepoint [1] 266891 0
Postoperative first 24 hours
Secondary outcome [1] 276573 0
The cumulative number of uses of analgesic by using clinical assessments
Timepoint [1] 276573 0
Postoperative first 24 hours
Secondary outcome [2] 276574 0
pain scores by using clinical assessments
Timepoint [2] 276574 0
Postoperative first 24 hours

Eligibility
Key inclusion criteria
American Society of Anesthesiologist (ASA) class I-II children between 2 and 8 years of age, who were scheduled for unilateral inguinal hernia repair
Minimum age
2 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychiatric illness, kidney failure and known hypersensitivity to relevant drugs.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3611 0
Turkey
State/province [1] 3611 0

Funding & Sponsors
Funding source category [1] 267182 0
Hospital
Name [1] 267182 0
Hospital of Gaziantep University
Country [1] 267182 0
Turkey
Primary sponsor type
Individual
Name
Levent Sahin
Address
University st. 27310 Sehitkamil Gaziantep
Country
Turkey
Secondary sponsor category [1] 266255 0
None
Name [1] 266255 0
Address [1] 266255 0
Country [1] 266255 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269177 0
Ethical Committee of Gaziantep University Hospitals
Ethics committee address [1] 269177 0
Gaziantep University, University st. 27310, Sehitkamil, GAziantep
Ethics committee country [1] 269177 0
Turkey
Date submitted for ethics approval [1] 269177 0
Approval date [1] 269177 0
16/12/2010
Ethics approval number [1] 269177 0
4/12/2010

Summary
Brief summary
The present study was designed to evaluate the analgesic efficacy of ultrasound-guided transversus abdominis plane block with high volume local anesthetic during the first 24 hours after surgery in pediatric patients undergoing inguinal hernia repair. Fifty seven children between 2 to 8 years of age undergoing unilateral inguinal hernioraphy were randomized to undergo a transversus abdominis plane block or to the infiltration anesthesia as control group. Intervention(s): A TAP block was performed using the ultrasound-guided technique with 0.5 mL/kg 0.25 % levobupivacaine volume on the ipsilateral side to the hernia under general anesthesia.
Main outcome measures: First analgesic requirement time, cumulative number of uses of analgesic, pain scores and adverse effects were assessed over the course of 24 hours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32694 0
Address 32694 0
Country 32694 0
Phone 32694 0
Fax 32694 0
Email 32694 0
Contact person for public queries
Name 15941 0
Levent Sahin
Address 15941 0
Gaziantep University, University st. 27310, SEhitkamil Gaziantep
Country 15941 0
Turkey
Phone 15941 0
00 90 342 3606060 # 77804
Fax 15941 0
Email 15941 0
drlsahin@hotmail.com
Contact person for scientific queries
Name 6869 0
Levent Sahin
Address 6869 0
Gaziantep University, University st. 27310, SEhitkamil Gaziantep
Country 6869 0
Turkey
Phone 6869 0
00 90 342 3606060 # 77804
Fax 6869 0
Email 6869 0
drlsahin@hotmail.com

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.