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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03845972
Other study ID # ??.2/44/2561
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2018
Est. completion date January 4, 2019

Study information

Verified date February 2019
Source Thammasat University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 4, 2019
Est. primary completion date January 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Procedure:
SSFTB
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.

Locations

Country Name City State
Thailand Ratibhorn Rangsee Klong Luang Pratumthani

Sponsors (1)

Lead Sponsor Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary quadriceps strength Quadriceps strength will be assessed as MVIC with handheld dynamometer (HHD, Lafayette Instrument, Lafayette, IN). 30 minutes after SSFTB
Secondary 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. 30 minutes after SSFTB
Secondary 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. 30 minutes after SSFTB
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