Condition category
Surgery
Date applied
18/09/2017
Date assigned
20/09/2017
Last edited
10/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Regional anesthesia is the use of local anesthetics to block sensations of pain from a large area of the body, such as the leg. Regional anesthesia of the leg usually consists of injections of local anesthetic close to two nerves called the sciatic and femoral. Normally this technique involves two needle punctures at different sites, one in the groin area, and one in the buttock, including the need to reposition the patient. The aim of this study is to investigate the feasibility of a new technique of blocking both nerves from the single injection site located at the upper thigh without repositioning the patient.

Who can participate?
Children aged 5-18 undergoing lower limb surgery below the middle of the thigh

What does the study involve?
All participants receive sciatic and femoral nerve blocks according to the new technique in the operating theatre. The possibility of blocking both nerves from one injection site is checked. The mean distances from skin to nerves are measured. After surgery pain intensity is assessed after 1, 3, 6, 12 and 24 hours.

What are the possible benefits and risks of participating?
Patients undergo thorough monitoring of their pain after surgery and receive rescue analgesic (painkiller) drugs as soon as they are needed. The risks of participating in the study include hematoma (bruise) formation due to unintentional puncture of blood vessels in the region of the block.

Where is the study run from?
Lviv Regional Childrens’ Clinic Hospital (Ukraine)

When is the study starting and how long is it expected to run for?
January 2017 to April 2017

Who is funding the study?
Lviv Regional Childrens' Clinic Hospital (Ukraine)

Who is the main contact?
Dr Andrew Albokrinov
a.albokrinov@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Albokrinov

ORCID ID

http://orcid.org/0000-0001-7401-4059

Contact details

Shyroka 70/32
Lviv
79052
Ukraine
+380 (0)672867103
a.albokrinov@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3-14-12-16

Study information

Scientific title

Lateral supratrochanteric approach to sciatic and femoral nerve blocks in children: a feasibility study

Acronym

Study hypothesis

Femoral and sciatic nerves can be blocked from the single needle insertion point located at the junction of lower and middle third of distance between the greater trochanter and iliac crest along the mid-axillary line.

Ethics approval

Lviv Regional Children’s Hospital Ethics Committee, 14/12/2016, Protocol #3

Study design

Interventional open label non-randomized single centre 4-month feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Lower extremity surgery

Intervention

Single shot neurostimulator-guided sciatic and femoral nerve blocks with bupivacaine 0.25% 0.3 ml/kg and 0.3 ml/kg respectively.

All participants received sciatic and femoral neve blocks in the operating theatre. The possibility of blocking two nerves (eliciting of motor response) from one injection site was checked. Mean distances from skin to nerves were registered. After surgery pain intensity was assessed after 1, 3, 6, 12 and 24 hours.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

1. The possibility of single injection site sciatic and femoral nerve blocks:
1.1. The possibility to perform sciatic nerve block from supratrochanteric area along mid-axillary line was assessed once at the moment of performing the block and was defined as possibility of eliciting motor response (plantar flexion) on neurostimulation with following neurostimulator settings: current 0.4 mA, impulse duration 0.3 ms and impulse frequency 2 Hz
1.2. The possibility to perform femoral nerve block from the same point also was assessed once at the moment of performing the block and was defined as possibility of eliciting motor response (patellar twitches) on neurostimulation with the same settings

Secondary outcome measures

1. Skin to nerve distances assessed once at the moment of performing the blocks using insulated needles with centimeter markings (Stimuplex A, 21G, 150 mm, B.Braun, Melsungen, Germany). The depth of needle insertion equaled to skin-to-corresponding nerve distance.
2. Pain intensity assessed according to Numeric Rating Scale (NRS, 0-10 points) during the first postoperative day at 1, 3, 6, 12 and 24 postoperative hours

Overall trial start date

01/01/2017

Overall trial end date

30/04/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 5-18 year old children of both genders undergoing lower limb surgery below middle of thigh
2. ASA status 1 or 2
3. Parental written informed consent for SNB, FNB and study participation

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Anatomical abnormality in block region
2. Contraindications to regional anesthesia

Recruitment start date

09/01/2017

Recruitment end date

11/04/2017

Locations

Countries of recruitment

Ukraine

Trial participating centre

Lviv Regional Childrens' Clinic Hospital
Lysenka 31
Lviv
79008
Ukraine

Sponsor information

Organisation

Lviv Regional Childrens' Clinic Hospital

Sponsor details

Lysenka 31
Lviv
79008
Ukraine
+380 (0)322759325
lodcl.oxmatdyt@gmail.com

Sponsor type

Hospital/treatment centre

Website

lodcl.oxmatdyt@gmail.com

Funders

Funder type

Hospital/treatment centre

Funder name

Lviv Regional Childrens' Clinic Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study protocol is not published and is not available online. Study protocol and statistical analysis are stored on investigators’ personal computers and are available upon request (a.albokrinov@gmail.com). The manuscript has been reviewed and will be published in 2017.

IPD sharing statement
Patients’ data sheets are stored at the repository of Lviv regional Childrens’ Clinic Hospital and are available upon request. These data sheets can be obtained immediately after written request approval by hospital authority. Statistical analysis is stored on personal computers of the investigators and can be provided upon request (a.albokrinov@gmail.com). Written informed parental consent was obtained in all cases and additional patients’ consents were obtained in case if patient was 14 or more years old. Patients were anonymized by registering only initials and patients’ numbers in data sheets.

Intention to publish date

31/12/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29213283

Publication citations

Additional files

Editorial Notes

10/07/2018: Publication reference added.