Effect of Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength

Effect of Ultrasound-guided Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength

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)

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Regional Anesthesia Morbidity; Saphenous Nerve Block
• Intervention / Treatment: Procedure: SSFTB

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Pratumthani
    • Klong Luang, Pratumthani, Thailand, 12120
      • Ratibhorn Rangsee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: before SSFTB
Experimental: after SSFTB	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.; Other Names: nerve to vastus medialis and saphenous nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quadriceps strength	Quadriceps strength will be assessed as MVIC with handheld dynamometer (HHD, Lafayette Instrument, Lafayette, IN).	30 minutes after SSFTB

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Thammasat University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): January 4, 2019
• Study Completion (Actual): January 4, 2019

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: February 16, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 16, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ทป.2/44/2561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No