ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Regional Anesthesia

Condition category

Condition code

Anaesthesiology

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]

Treatment: Surgery

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

immediately after block

Secondary outcome [1]

Clinical efficacy (motor response on incision). If there was no patients' movements on incision we assumed that block was effective.

Timepoint [1]

Beginning of the surgery (incision).

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Ukraine

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Lviv Regional Children's Clinic Hospital

Address [1]

Lysenka str. 31, Lviv 79008, Ukraine

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Lviv Regional Children’s Hospital Ethics Committee

Ethics committee address [1]

Lysenka str. 31, Lviv 79008

Ethics committee country [1]

Ukraine

Date submitted for ethics approval [1]

18/01/2016

Approval date [1]

27/01/2016

Ethics approval number [1]

1-1-2016

Summary

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

Contacts

Principal investigator

Name

Dr Andrew Albokrinov

Address

Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.

Country

Ukraine

Phone

+380672867103

Fax

a.albokrinov@gmail.com

Contact person for public queries

Name

Andrew Albokrinov

Address

Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.

Country

Ukraine

Phone

+380672867103

Fax

a.albokrinov@gmail.com

Contact person for scientific queries

Name

Andrew Albokrinov

Address

Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.

Country

Ukraine

Phone

+380672867103

Fax

a.albokrinov@gmail.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

Source	Title	Year of Publication	DOI
Embase	A new neurostimulator guided technique of rectus sheath block: Study of feasibility and local anesthetic spread in children.	2019	https://dx.doi.org/10.5114/ait.2019.85871

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically