Effect of Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength
Primary Purpose
Saphenous Nerve Block, Regional Anesthesia Morbidity, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
SSFTB
Sponsored by

About this trial
This is an interventional treatment trial for Saphenous Nerve Block
Eligibility Criteria
Inclusion Criteria:
- Eligible patients are all ASA class I-III, age 18-80 years, and have plan to perform SSFTB at Thammasat University Hospital consecutively
Exclusion Criteria:
- Exclusion criteria are patients who refuse to participate the study, morbid obesity (BMI ≥ 35 kg.m2), lower extremity neurological dysfunction, performing other peripheral nerve blocks, patients who cannot cooperate or measure MVIC, difference of quadriceps strength between two side of knees more than 10 percent, and SSFTB is not finally performed or failed block.
Sites / Locations
- Ratibhorn Rangsee
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
before SSFTB
after SSFTB
Arm Description
Outcomes
Primary Outcome Measures
quadriceps strength
Quadriceps strength will be assessed as MVIC with handheld dynamometer (HHD, Lafayette Instrument, Lafayette, IN).
Secondary Outcome Measures
motor power of knee extension
The muscle power will be graded compared to another leg: 0 = No motor block, 1 = partial motor block, 2 = complete motor block.
perception of fall 30 minutes
If the patient can be able to stand independently for at least 30 seconds without support, he or she will be asked to do functional reach test, which the patient should reach forward by staying put feet. The difference of starting and ending point of the reaching hand will be measured. If the patient cannot stand independently for at least 30 seconds without support or do functional reach test less than 25 cm indicates that he or she has a higher risk for falls.
Full Information
NCT ID
NCT03845972
First Posted
January 19, 2019
Last Updated
February 16, 2019
Sponsor
Thammasat University
1. Study Identification
Unique Protocol Identification Number
NCT03845972
Brief Title
Effect of Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength
Official Title
Effect of Ultrasound-guided Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
January 4, 2019 (Actual)
Study Completion Date
January 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research objective is to compare quadriceps strength by measuring maximal voluntary isometric contraction (MVIC) and risk of fall before and after subsartorial femoral triangle block (SSFTB)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Saphenous Nerve Block, Regional Anesthesia Morbidity, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
before SSFTB
Arm Type
No Intervention
Arm Title
after SSFTB
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
SSFTB
Other Intervention Name(s)
nerve to vastus medialis and saphenous nerve block
Intervention Description
Patients who underwent major knee surgery and had already planned to perform subsartorial femoral triangle block (SSFTB) were included in the study. They were measured the outcomes the night before surgery. The saphenous nerve and nerve to vastus medialis were blocked at the subsartorial femoral triangle level by experienced anesthesiologists. After standard monitor, the distal femoral triangle was identified 2 cm proximal to the opening of adductor canal by ultrasound guidance. At this level, The location of nerve to vastus medialis was confirmed by nerve stimulator and it was blocked with 0.5% levobupivacaine 5 ml. Then, 0.5% levobupivacaine 10 ml would be injected perifemoral artery. The outcomes were re-assessed 30 min after block.
Primary Outcome Measure Information:
Title
quadriceps strength
Description
Quadriceps strength will be assessed as MVIC with handheld dynamometer (HHD, Lafayette Instrument, Lafayette, IN).
Time Frame
30 minutes after SSFTB
Secondary Outcome Measure Information:
Title
motor power of knee extension
Description
The muscle power will be graded compared to another leg: 0 = No motor block, 1 = partial motor block, 2 = complete motor block.
Time Frame
30 minutes after SSFTB
Title
perception of fall 30 minutes
Description
If the patient can be able to stand independently for at least 30 seconds without support, he or she will be asked to do functional reach test, which the patient should reach forward by staying put feet. The difference of starting and ending point of the reaching hand will be measured. If the patient cannot stand independently for at least 30 seconds without support or do functional reach test less than 25 cm indicates that he or she has a higher risk for falls.
Time Frame
30 minutes after SSFTB
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible patients are all ASA class I-III, age 18-80 years, and have plan to perform SSFTB at Thammasat University Hospital consecutively
Exclusion Criteria:
Exclusion criteria are patients who refuse to participate the study, morbid obesity (BMI ≥ 35 kg.m2), lower extremity neurological dysfunction, performing other peripheral nerve blocks, patients who cannot cooperate or measure MVIC, difference of quadriceps strength between two side of knees more than 10 percent, and SSFTB is not finally performed or failed block.
Facility Information:
Facility Name
Ratibhorn Rangsee
City
Klong Luang
State/Province
Pratumthani
ZIP/Postal Code
12120
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength
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