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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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
Control group

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

Key inclusion criteria
elective umbilical or paraumbilical hernia surgery, 1-2 ASA physical status
Minimum age
1 Years
Maximum age
15 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Urgent surgery, >2 ASA physical status, lack of parental consent

Study design
Purpose of the study
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 9389 0
State/province [1] 9389 0

Funding & Sponsors
Funding source category [1] 298048 0
Name [1] 298048 0
Lviv Regional Children's Clinic Hospital
Address [1] 298048 0
Lysenka str. 31, Lviv 79008, Ukraine
Country [1] 298048 0
Primary sponsor type
Andrew Albokrinov
Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.
Secondary sponsor category [1] 297122 0
Name [1] 297122 0
Address [1] 297122 0
Country [1] 297122 0

Ethics approval
Ethics application status
Ethics committee name [1] 299070 0
Lviv Regional Children’s Hospital Ethics Committee
Ethics committee address [1] 299070 0
Lysenka str. 31, Lviv 79008
Ethics committee country [1] 299070 0
Date submitted for ethics approval [1] 299070 0
Approval date [1] 299070 0
Ethics approval number [1] 299070 0

Brief summary
Rectus sheath block is a valuable regional technique for abdominal wall midline analgesia. It can be used for variety of surgical procedures such as midline laparotomy, umbilical and paraumbilical hernia repair, and laparoscopic surgery. Not all operating theatres, especially in low income countries, are equipped with ultrasound scanners for carrying out US guided regional blocks. In cases of total absence of objective control, neurostimulator guided technique of RSB can be useful. Objective of the study was to check the feasibility of performing neurostimulator guided rectus sheath block. Neurostimulator guided RSB was performed on patients who underwent umbilical or paraumbilical hernia surgery. After performing the block ultrasound scanning of block area and clinical efficacy assessment was performed. Optimal spread of local anaesthetic was achieved in 86 cases (74.14%), and suboptimal spread – in 30 cases (25.86%) of neurostimulator guided rectus sheath blocks. There were no cases of non-optimal local anaesthetic spread. In all cases neurostimulator guided rectus sheath block had high clinical efficacy (there was no motor response to incision and no need for fentanyl administration). We conclude that rectus sheath block can be performed under neurostimulator guidance. Neurostimulator guided rectus sheath block resulted in optimal or suboptimal local anaesthetic spread. Clinical efficacy of neurostimulator guided rectus sheath block was high.

Sample size was 58 patients. Neurostimulator guided rectus sheath block was performed bilaterally to each of them. So there were 116 rectus sheath blocks performed. Of them there were 86 optimal and 30 suboptimal spread of local anesthetic.
Trial website
Trial related presentations / publications
Public notes

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
Phone 79190 0
Fax 79190 0
Email 79190 0
Contact person for public queries
Name 79191 0
Dr Andrew Albokrinov
Address 79191 0
Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.
Country 79191 0
Phone 79191 0
Fax 79191 0
Email 79191 0
Contact person for scientific queries
Name 79192 0
Dr Andrew Albokrinov
Address 79192 0
Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.
Country 79192 0
Phone 79192 0
Fax 79192 0
Email 79192 0

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary