Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000553279
Ethics application status
Approved
Date submitted
22/11/2017
Date registered
13/04/2018
Date last updated
13/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A New Technique of Abdominal Wall Anesthesia: A Feasibility Study in Children
Scientific title
A New Neurostimulator Guided Technique of Rectus Sheath Block: Study of Feasibility and Local Anesthetic Spread in Children
Secondary ID [1] 293423 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Regional Anesthesia 305580 0
Condition category
Condition code
Anaesthesiology 304810 304810 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After induction of general anesthesia we performed neurostimulator guided bilateral rectus sheath block in 58 children (average age 34.5 months, body mass 16.4 kg) with ultrasound assessment of block area after doing the blockade in order to chek if local anesthetic have spread properly.
Materials: Ultrasound scanner SonoSite Titan; SonoSite Inc., Washington, USA; Neurostimulator Stimuplex HNS 12, B.Braun, Melsungen, Germany; Insulated needle Stimuplex A, 21G, 50 mm, B.Braun, Melsungen, Germany
Drugs: Bupivacaine 0.25% 0.3 ml/kg for each side.
Operator: Pediatric anesthesiologist with at least 10 years experience in pediatric anesthesia and 5 years experience in regional anesthesia.
The number of times: Once.
The location: Operating theatre in teaching hospital.
Intervention code [1] 299665 0
Treatment: Surgery
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304020 0
Proper local anesthetic spread between rectus abdominis muscle and its posterior sheath. It was assesssed by ultrasound examination of block area immediately after procedure. According to scanning results all neurostimulator guided rectus sheath blocks were divided into 3 groups as follows: optimal spread (local anesthetic solution is between rectus abdominis muscle and posterior rectus sheath), suboptimal spread (most of local anesthetic solution is between rectus abdominis muscle and posterior rectus sheath, infiltration of rectus abdominis muscle with local anesthetic is evident) and non-optimal spread (local anesthetic solution is in the rectus abdominis muscle tissue, there is no or minimum of local anesthetic between rectus abdominis muscle and posterior rectus sheath).
Timepoint [1] 304020 0
immediately after block
Secondary outcome [1] 340731 0
Clinical efficacy (motor response on incision). If there was no patients' movements on incision we assumed that block was effective.
Timepoint [1] 340731 0
Beginning of the surgery (incision).
Secondary outcome [2] 343009 0
Clinical efficacy (fentanyl requirements). If patient demonstrated hemodynamic response (tachycardia, hypertension) on surgery we added fentanyl 1 mcg/kg. If there was no need to add fentanyl during surgery we assumed that the block is effective.
Timepoint [2] 343009 0
End of surgery

Eligibility
Key inclusion criteria
elective umbilical or paraumbilical hernia surgery, 1-2 ASA physical status
Minimum age
1 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Urgent surgery, >2 ASA physical status, lack of parental consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
8/11/2016
Date of last data collection
Anticipated
Actual
8/11/2016
Sample size
Target
50
Accrual to date
Final
58
Recruitment outside Australia
Country [1] 9389 0
Ukraine
State/province [1] 9389 0

Funding & Sponsors
Funding source category [1] 298048 0
Hospital
Name [1] 298048 0
Lviv Regional Children's Clinic Hospital
Country [1] 298048 0
Ukraine
Primary sponsor type
Individual
Name
Andrew Albokrinov
Address
Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.
Country
Ukraine
Secondary sponsor category [1] 297122 0
None
Name [1] 297122 0
Address [1] 297122 0
Country [1] 297122 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299070 0
Lviv Regional Children’s Hospital Ethics Committee
Ethics committee address [1] 299070 0
Ethics committee country [1] 299070 0
Ukraine
Date submitted for ethics approval [1] 299070 0
18/01/2016
Approval date [1] 299070 0
27/01/2016
Ethics approval number [1] 299070 0
1-1-2016

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

Contacts
Principal investigator
Name 79190 0
Dr Andrew Albokrinov
Address 79190 0
Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.
Country 79190 0
Ukraine
Phone 79190 0
+380672867103
Fax 79190 0
Email 79190 0
[email protected]
Contact person for public queries
Name 79191 0
Andrew Albokrinov
Address 79191 0
Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.
Country 79191 0
Ukraine
Phone 79191 0
+380672867103
Fax 79191 0
Email 79191 0
[email protected]
Contact person for scientific queries
Name 79192 0
Andrew Albokrinov
Address 79192 0
Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.
Country 79192 0
Ukraine
Phone 79192 0
+380672867103
Fax 79192 0
Email 79192 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
EmbaseA new neurostimulator guided technique of rectus sheath block: Study of feasibility and local anesthetic spread in children.2019https://dx.doi.org/10.5114/ait.2019.85871
N.B. These documents automatically identified may not have been verified by the study sponsor.