NCT03845972

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

January 19, 2019

Last Update Submit

February 16, 2019

Conditions

Saphenous Nerve BlockRegional Anesthesia MorbidityPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • quadriceps strength

    Quadriceps strength will be assessed as MVIC with handheld dynamometer (HHD, Lafayette Instrument, Lafayette, IN).

    30 minutes after SSFTB

Secondary Outcomes (2)

  • motor power of knee extension

    30 minutes after SSFTB

  • perception of fall 30 minutes

    30 minutes after SSFTB

Study Arms (2)

before SSFTB

NO INTERVENTION

after SSFTB

EXPERIMENTAL
Procedure: SSFTB

Interventions

SSFTBPROCEDURE

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.

Also known as: nerve to vastus medialis and saphenous nerve block
after SSFTB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible patients are all ASA class I-III, age 18-80 years, and have plan to perform SSFTB at Thammasat University Hospital consecutively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ratibhorn Rangsee

Klong Luang, Pratumthani, 12120, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 19, 2019

First Posted

February 19, 2019

Study Start

April 25, 2018

Primary Completion

January 4, 2019

Study Completion

January 4, 2019

Last Updated

February 19, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)