Lateral upper thigh approach to sciatic and femoral nerve blocks in children
| ISRCTN | ISRCTN70969666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70969666 |
| Secondary identifying numbers | 3-14-12-16 |
- Submission date
- 18/09/2017
- Registration date
- 20/09/2017
- Last edited
- 10/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Shyroka 70/32
Lviv
79052
Ukraine
 ORCID ID |
0000-0001-7401-4059 |
|---|---|
| Phone | +380 (0)672867103 |
| a.albokrinov@gmail.com |
Study information
| Study design | Interventional open label non-randomized single centre 4-month feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Lateral supratrochanteric approach to sciatic and femoral nerve blocks in children: a feasibility study |
| Study objectives | 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(s) | Lviv Regional Children’s Hospital Ethics Committee, 14/12/2016, Protocol #3 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2017 |
| Completion date | 30/04/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key exclusion criteria | 1. Anatomical abnormality in block region 2. Contraindications to regional anesthesia |
| Date of first enrolment | 09/01/2017 |
| Date of final enrolment | 11/04/2017 |
Locations
Countries of recruitment
- Ukraine
Study participating centre
Lviv
79008
Ukraine
Sponsor information
Hospital/treatment centre
Lysenka 31
Lviv
79008
Ukraine
| Phone | +380 (0)322759325 |
|---|---|
| lodcl.oxmatdyt@gmail.com | |
| Website | lodcl.oxmatdyt@gmail.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2017 | Yes | No |
Editorial Notes
10/07/2018: Publication reference added.
