Trial Review

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
ACTRN12615000856516
Ethics application status
Approved
Date submitted
5/09/2014
Date registered
17/08/2015
Date last updated
17/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of ultrasound with or without nerve stimulator for infraclavicular brachial plexus block in children undergoing elective upper extremity orthopedic surgery
Scientific title
Efficacy of ultrasound with or without nerve stimulator for lateral sagittal infraclavicular brachial plexus block in children undergoing elective upper extremity orthopedic surgery
Secondary ID [1] 285374 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anesthesia for pediatric upper extremity elective surgery 292958 0
Condition category
Condition code
Anaesthesiology 293252 293252 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound with nerve stimulator for infraclavicular brachial plexus block in children undergoing elective upper extremity orthopedic surgery, intervention arm is the injured arm and did not apply anything to healty arm
Lateral sagittal infraclavicular brachial plexus block with neurostimulator was applied to injured arm at a dose of 0.5 mg per kg levobupivacaine after general anesthesia induction and before surgery starts. The stimulator was initially adjusted to the parameters of 1.0 mA, 2 Hz, 0.1 ms. The insertion was performed with the sagittal plane in an anteroposterior manner at a 30–45 degrees angle from the intervention point to the ground where the patient was lying. When twitching response was obtained from one of the nerves , the current was reduced to 0.5 mA and this was considered to be an indicator of successful localization of nerve.
To perform the ultrasound for the nerve block, a General Electric (GE) LOGIQ e model Linear Multifrequency 12L probe (GE Medical Systems, Phoenix-USA) was used. Multistimpleks (Pajunk, Germany) was used as nerve stimulator, and a custom needle specific to plexus anesthesia, Stimupleks A (B. Braun Melsungen AG, Japan) 21G, 50 mm was used as the needle. The USG probe was placed in the sagittal plane 1 cm under the conjunction of the clavicle and coracoid process. After the axillary artery and cords were identified, the stimulation needle was advanced (with the in-plane technique) to be in the same plane as the USG probe.
Intervention code [1] 290190 0
Treatment: Devices
Intervention code [2] 291507 0
Treatment: Drugs
Comparator / control treatment
An infraclavicular brachial plexus nerve block was performed at a dose of 0.5 ml/kg of 0.5% levobupivacaine in Group 1 with USG, Group 2 with USG plus neurostimulator, and Group 3 with only neurostimulator. Standart treatment (0.5 ml/kg of 0.5% levobupivacaine) is used in 3 groups.
Control group
Active

Outcomes
Primary outcome [1] 293102 0
The time when the first postoperative analgesic was required was recorded as the duration of sensory block.
Timepoint [1] 293102 0
Immediately after administration of first analgesic
Primary outcome [2] 293103 0
the time when the first movement was observed in the upper extremity or hand was recorded as the duration of motor block
Timepoint [2] 293103 0
From the end of surgery to the time when patient was able to move hands postoperatively.
Primary outcome [3] 293104 0
Postoperative analgesia was evaluated via the Wong Baker Faces Scale.
Timepoint [3] 293104 0
Post operative 3., 6. And 12. Hr
Secondary outcome [1] 310339 0
Skin - needle depth to point where drug applied with USG and neurostimulator
Timepoint [1] 310339 0
From the begining of nerve block procedure to the end of drug application
Secondary outcome [2] 310594 0
Total intervention (brachial plexus block procedure) time in minutes
Timepoint [2] 310594 0
From the begining of nerve block procedure to the end of drug application

Eligibility
Key inclusion criteria
patient group who would have an elective upper extremity orthopedic surgery
Minimum age
2 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
neurological deficits, mental retardation, local anesthetic allergy, coagulopathy, under chronic analgesic treatment, skin infections at the site of the block, history of shoulder surgery on nerve block side, and not have family consent

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
87 pediatric trauma patients were scheduled for surgery in pediatric ortophedics within the study time period. 7 patients did not accept regional anesthesia, 3 patient had a risk of neurologic deficit after surgery, 2 patient had mental retardation and 3 patient had history of shoulder surgery on nerve block side so 15 patients excluded from study. Others were randomly split into double blind 3 groups of 24 patients.
All values are expressed as mean +/- SD. The SPSS 7.0 program was used for statistical analyses. Differences in height, weight, block time, needle depth, and sensorial and motor block duration were evaluated using an independent t test. The Mann-Whitney U test and chi-squared tests were used to evaluate intergroup differences in VPS and motor and sensorial block durations. P<0.05 was considered significant. Post hoc analysis was used for group participant numbers. Power was calculated as: %83

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/02/2012
Actual
16/02/2012
Date of last participant enrolment
Anticipated
Actual
26/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
87
Recruitment outside Australia
Country [1] 6338 0
Turkey
State/province [1] 6338 0

Funding & Sponsors
Funding source category [1] 289911 0
Hospital
Name [1] 289911 0
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi
Country [1] 289911 0
Turkey
Primary sponsor type
Hospital
Name
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi
Address
Tevfik Saglam Caddesi No:11 Bakirkoy/Istanbul
Country
Turkey
Secondary sponsor category [1] 289434 0
None
Name [1] 289434 0
Address [1] 289434 0
Country [1] 289434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291630 0
Local Instutional Ethic Committee
Ethics committee address [1] 291630 0
Ethics committee country [1] 291630 0
Turkey
Date submitted for ethics approval [1] 291630 0
09/12/2010
Approval date [1] 291630 0
21/04/2011
Ethics approval number [1] 291630 0
9

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

Contacts
Principal investigator
Name 51242 0
Dr Aycan Guner Ekici
Address 51242 0
Dr. Aycan Guner Ekici Dolapdere caddesi 193/3 34375 Pangalti Sisli / Istanbul Istanbul Kartal Research and Training Hospital
Country 51242 0
Turkey
Phone 51242 0
+90 5305004052
Fax 51242 0
Email 51242 0
[email protected]
Contact person for public queries
Name 51243 0
Aycan Guner Ekici
Address 51243 0
Dr. Aycan Guner Ekici Dolapdere caddesi 193/3 34375 Pangalti Sisli / Istanbul Istanbul Kartal Research and Training Hospital
Country 51243 0
Turkey
Phone 51243 0
+90 5305004052
Fax 51243 0
Email 51243 0
[email protected]
Contact person for scientific queries
Name 51244 0
Aycan Guner Ekici
Address 51244 0
Dr. Aycan Guner Ekici Dolapdere caddesi 193/3 34375 Pangalti Sisli / Istanbul Istanbul Kartal Research and Training Hospital
Country 51244 0
Turkey
Phone 51244 0
+90 5305004052
Fax 51244 0
Email 51244 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.