Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001074886
Ethics application status
Approved
Date submitted
4/10/2012
Date registered
8/10/2012
Date last updated
8/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound-guided transversus abdominis plane block versus caudal block for pain relief in children
Scientific title
Ultrasound-guided transversus abdominis plane block versus caudal block for postoperative pain control in children undergoing groin surgery
Secondary ID [1] 281343 0
Nil
Universal Trial Number (UTN)
U1111-1135-4777
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Pain
Anesthesia 287569 0
Condition category
Condition code
Anaesthesiology 287895 287895 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anesthesia will be induced with sevoflurane and followed by placement of a laryngeal mask airway. Then a single Ultrasound-guided transversus abdominis plane block will be administered with levobupivacaine 0.25% 0.4mL/kg
Intervention code [1] 285809 0
Treatment: Drugs
Comparator / control treatment
Anesthesia will be induced with sevoflurane and followed by placement of a laryngeal mask airway. Then a single caudal block be administered with levobupivacaine 0.25% 1mL/kg
Control group
Active

Outcomes
Primary outcome [1] 288107 0
Time to first rescue medication
Timepoint [1] 288107 0
From the data of intervention until the data of the first registration of a CHIPPS scores larger than 3, assessed up to 24h
Primary outcome [2] 288108 0
the number of patients not requiring rescue analgesia
Timepoint [2] 288108 0
After surgery, up to 24h
Secondary outcome [1] 299441 0
Postoperative pain intensity

The quality of postoperative pain control was assessed by the Children and Infants Postoperative Pain Scale (CHIPPS)
Timepoint [1] 299441 0
after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h, assessed up to 24h
Secondary outcome [2] 299442 0
the incidence of emergence agitation

The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)
Timepoint [2] 299442 0
Participants will be followed for the duration of PACU stay, an expected average of 2 h.
Secondary outcome [3] 299443 0
Residual motor block

The degree of motor blockade was assessed using a modified Bromage scale
Timepoint [3] 299443 0
After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h
Secondary outcome [4] 299444 0
the sedation score

Sedation was assessed using the Modified Ramsay Sedation Score
Timepoint [4] 299444 0
After surgery,every 15min for the first 2 h and every 30min for the next 2h.
Secondary outcome [5] 299445 0
Side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention
Timepoint [5] 299445 0
From the administration of the transversus abdominis plane / caudal block until the end of study period, assessed up to postoperative 24h

Eligibility
Key inclusion criteria
ASA ststus I-II aged 2-5yr undergoing unilateral inguinal hernia repair
Minimum age
2 Years
Maximum age
5 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Hypersensitivity to any local anesthetics
Infections at puncture sites
Bleeding diathesis
Preexisting neurological disease

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)
Allocation was concealed by sealed opaque envelopes that were opened by a nurse not involved with the care of the individuals.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/10/2012
Actual
9/10/2012
Date of last participant enrolment
Anticipated
Actual
5/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 4585 0
China
State/province [1] 4585 0
Fujian

Funding & Sponsors
Funding source category [1] 286108 0
Self funded/Unfunded
Name [1] 286108 0
Yusheng Yao
Country [1] 286108 0
China
Funding source category [2] 286109 0
Self funded/Unfunded
Name [2] 286109 0
Yanqing Chen
Country [2] 286109 0
China
Primary sponsor type
Individual
Name
Yusheng Yao
Address
No.134 Dongjie Street, Fuzhou, Fujian, China, 350001
Country
China
Secondary sponsor category [1] 284921 0
Individual
Name [1] 284921 0
Yanqing Chen
Address [1] 284921 0
No.134 Dongjie Street, Fuzhou, Fujian, China, 350001
Country [1] 284921 0
China
Other collaborator category [1] 277114 0
Individual
Name [1] 277114 0
Lin Tan
Address [1] 277114 0
NO.37, Guoxue Alley, Chengdu, Sichuan, China,610041
Country [1] 277114 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288156 0
Medical Ethics Committee of Fujian Provincial Hospital
Ethics committee address [1] 288156 0
Ethics committee country [1] 288156 0
China
Date submitted for ethics approval [1] 288156 0
11/09/2012
Approval date [1] 288156 0
27/09/2012
Ethics approval number [1] 288156 0
FJ20120927

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34792 0
Dr Yusheng Yao
Address 34792 0
No.134, Dongjie Street, Fuzhou, Fujian,China,350001
Country 34792 0
China
Phone 34792 0
+86 13559939629
Fax 34792 0
Email 34792 0
[email protected]
Contact person for public queries
Name 18039 0
Yanqing Chen
Address 18039 0
No.134, Dongjie Street, Fuzhou, Fujian,China,350001
Country 18039 0
China
Phone 18039 0
+86 591-87557768-7096
Fax 18039 0
Email 18039 0
[email protected]
Contact person for scientific queries
Name 8967 0
Yusheng Yao
Address 8967 0
No.134, Dongjie Street, Fuzhou, Fujian,China,350001
Country 8967 0
China
Phone 8967 0
+86 13559939629
Fax 8967 0
Email 8967 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.