Sciatic Nerve BlockNCT03678961
The Effect of Leg Position on the Sciatic Nerve on Sonogram
An observational study of Sciatic Nerve Block, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Little is known about which posture of lower extremity makes it easier to access to the sciatic nerve. In this study, the investigators aimed to identify the most appropriate positioning of the lower extremity during anterior-approach ultrasound-guided sciatic nerve block. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sciatic Nerve Block
- What is being tested?
- external rotation of leg and hip flexion and knee flexion
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2018to 11 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing knee surgery requiring peripheral nerve block
Who may be able to join
- ASA PS 1-3
- patients undergoing knee surgery requiring peripheral nerve block
Who cannot join
- patients who refuse to participate in the study
- BMI > 40 kg/m2
- patients who have congenital abnormality on leg
- patients who have surgery or trauma on hip/knee
- patients who cannot move freely due to the contracture
- patients who are judged ineligible by the medical staff to participate in the study for other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Lower Extremity Positioning During Anterior-approach Ultrasound-guided Sciatic Nerve Block: Depth and Visibility
Little is known about which posture of lower extremity makes it easier to access to the sciatic nerve. In this study, the investigators aimed to identify the most appropriate positioning of the lower extremity during anterior-approach ultrasound-guided sciatic nerve block.
- Conditions
- Sciatic Nerve Block
- Being tested
- external rotation of leg, hip flexion and knee flexion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external rotation of legBehavioural
external rotation of leg by 45 degrees
hip flexion and knee flexionBehavioural
hip flexion by 15/45 degrees and knee flexion by 15/45 degrees
| Study group | Role | What they receive |
|---|---|---|
| Group N | Neutral position | |
| Group E | External rotation of leg by 45 degrees Receives: Behavioral: external rotation of leg | |
| Group EF45 | External rotation of leg by 45 degrees, hip flexion by 45 degrees, and knee flexion by 45 degrees Receives: Behavioral: external rotation of leg; Behavioral: hip flexion and knee flexion | |
| Group EF15 | External rotation of leg by 45 degrees, hip flexion by 15 degrees, and knee flexion by 15 degrees Receives: Behavioral: external rotation of leg; Behavioral: hip flexion and knee flexion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visibility of sciatic nerve
Visibility of sciatic nerve at each position assessed using a scoring system (0, no nerve identified; 1, nerve identified with a high probability; 2, nerve identified, but most of it not visible; 3, nerve identified, more than 50% of its borders can be precisely distinguished from surrounding structures; 4, nerve completely visible, but fascicles poorly defined; 5, nerve completely visible and multiple fascicles identifiable.)
Measured: during 10 minutes of anesthesia induction
Secondary outcomes (1)
Depth of sciatic nerve
Distance from skin to sciatic nerve at each position
Measured: during 10 minutes of anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start30 Aug 2018
- Primary completion11 Oct 2018
- Study completion11 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatic Nerve BlockStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajung Kim, Asan Medical Center
- Investigators
- Won Uk Koh, M.D., Ph.D., Principal investigator, University of Ulsan, College of Medicine, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678961
- Sponsor's protocol ID
- 2018-0970
- Status last verified
- Dec 2018
- First submitted
- 17 Aug 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Lower Extremity Positioning During Anterior-approach Ultrasound-guided Sciatic Nerve Block: Depth and Visibility
- ClinicalTrials.gov ID
- NCT03678961
- Acronym / sponsor ID
- 2018-0970
- Conditions
- Sciatic Nerve Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Little is known about which posture of lower extremity makes it easier to access to the sciatic nerve. In this study, the investigators aimed to identify the most appropriate positioning of the lower extremity during anterior-approach ultrasound-guided sciatic nerve block.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group N | – | –Neutral position |
| Group E | – | Behavioral: external rotation of legExternal rotation of leg by 45 degrees |
| Group EF45 | – | Behavioral: external rotation of leg, Behavioral: hip flexion and knee flexionExternal rotation of leg by 45 degrees, hip flexion by 45 degrees, and knee flexion by 45 degrees |
| Group EF15 | – | Behavioral: external rotation of leg, Behavioral: hip flexion and knee flexionExternal rotation of leg by 45 degrees, hip flexion by 15 degrees, and knee flexion by 15 degrees |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing knee surgery requiring peripheral nerve block
Key inclusion criteria (2 listed)
- ASA PS 1-3
- patients undergoing knee surgery requiring peripheral nerve block
Key exclusion criteria (6 listed)
- patients who refuse to participate in the study
- BMI > 40 kg/m2
- patients who have congenital abnormality on leg
- patients who have surgery or trauma on hip/knee
- patients who cannot move freely due to the contracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external rotation of legexternal rotation of leg by 45 degrees | Behavioural | Group E, Group EF15, Group EF45 |
| hip flexion and knee flexionhip flexion by 15/45 degrees and knee flexion by 15/45 degrees | Behavioural | Group EF15, Group EF45 |
Primary outcome
Visibility of sciatic nerve
Time frame: during 10 minutes of anesthesia induction
Visibility of sciatic nerve at each position assessed using a scoring system (0, no nerve identified; 1, nerve identified with a high probability; 2, nerve identified, but most of it not visible; 3, nerve identified, more than 50% of its borders can be precisely distinguished from surrounding structures; 4, nerve completely visible, but fascicles poorly defined; 5, nerve completely visible and multiple fascicles identifiable.)
1 secondary outcome
Depth of sciatic nerve
Time frame: during 10 minutes of anesthesia induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Uk Koh, M.D., Ph.D. principal investigator
University of Ulsan, College of Medicine, Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sciatic Nerve Block, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visibility of sciatic nerve (time frame: during 10 minutes of anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.