- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03678961
The Effect of Leg Position on the Sciatic Nerve on Sonogram
December 19, 2018 updated by: Hajung Kim, Asan Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 05505
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing knee surgery requiring peripheral nerve block
Description
Inclusion Criteria:
- ASA PS 1-3
- patients undergoing knee surgery requiring peripheral nerve block
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group N
Neutral position
|
|
Group E
External rotation of leg by 45 degrees
|
external rotation of leg by 45 degrees
|
Group EF45
External rotation of leg by 45 degrees, hip flexion by 45 degrees, and knee flexion by 45 degrees
|
external rotation of leg by 45 degrees
hip flexion by 15/45 degrees and knee flexion by 15/45 degrees
|
Group EF15
External rotation of leg by 45 degrees, hip flexion by 15 degrees, and knee flexion by 15 degrees
|
external rotation of leg by 45 degrees
hip flexion by 15/45 degrees and knee flexion by 15/45 degrees
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.)
|
during 10 minutes of anesthesia induction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depth of sciatic nerve
Time Frame: during 10 minutes of anesthesia induction
|
Distance from skin to sciatic nerve at each position
|
during 10 minutes of anesthesia induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 30, 2018
Primary Completion (ACTUAL)
October 11, 2018
Study Completion (ACTUAL)
October 11, 2018
Study Registration Dates
First Submitted
August 17, 2018
First Submitted That Met QC Criteria
September 19, 2018
First Posted (ACTUAL)
September 20, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 20, 2018
Last Update Submitted That Met QC Criteria
December 19, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 2018-0970
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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