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
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