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Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block for Quadriceps Strength and Fall-risk

Primary Purpose

Quadriceps Muscle Weakness, Adductor Muscle Weakness, Fall Risk

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ultrasound Guided Adductor Canal Block

Ultrasound Guided Femoral Nerve Block

About this trial

This is an interventional treatment trial for Quadriceps Muscle Weakness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adults (>18yrs)
ASA 1-2

Exclusion Criteria:

BMI >30
Allergy to local anesthetics
Pre-existing gait disturbance
Pre-existing neuropathy

Sites / Locations

St. Luke's Roosevelt Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Adductor Canal block first

Femoral nerve block first

Arm Description

This arm received an ultrasound guided adductor canal block with 15mL of chloroprocaine 3% followed by motor, sensory and balance assessments. Then the patients received an ultrasound guided femoral nerve block with 15mL of chloroprocaine 3% followed by sensory and motor assessments.

This arm received an ultrasound guided femoral nerve block with 15mL of chloroprocaine 3% followed by motor, sensory and balance assessments. Then the patients received an ultrasound guided adductor canal block with 15mL of chloroprocaine 3% followed by sensory and motor assessments.

Outcomes

Primary Outcome Measures

Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB

Secondary Outcome Measures

Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 60 mins after either an ACB or FNB

Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 30 mins after either an ACB or FNB

Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 60 mins after either an ACB or FNB

Assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes after the first nerve block.

Full Information

NCT ID

NCT01655277

First Posted

July 30, 2012

Last Updated

July 30, 2012

Sponsor

St. Luke's-Roosevelt Hospital Center

1. Study Identification

Unique Protocol Identification Number

NCT01655277

Brief Title

Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block for Quadriceps Strength and Fall-risk

Official Title

The Effects of Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block on Quadriceps Strength and Fall-risk: a Blinded Randomized Trial of Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Luke's-Roosevelt Hospital Center

4. Oversight

5. Study Description

Brief Summary

Our objective was to determine if an ultrasound guided ACB can preserve quadriceps strength, thus minimizing weakness of knee extension compared with ultrasound guided femoral nerve block. Our primary outcome was the percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB. Secondary outcomes included MVIC of knee extension at 60 min, hip adduction at 30 and 60 mins, and assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Quadriceps Muscle Weakness, Adductor Muscle Weakness, Fall Risk

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adductor Canal block first

Arm Type

Experimental

Arm Description

Arm Title

Femoral nerve block first

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Ultrasound Guided Adductor Canal Block

Intervention Type

Procedure

Intervention Name(s)

Ultrasound Guided Femoral Nerve Block

Primary Outcome Measure Information:

Title

Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB

Time Frame

At 30 minutes

Secondary Outcome Measure Information:

Title

Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 60 mins after either an ACB or FNB

Time Frame

At 60 minutes

Title

Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 30 mins after either an ACB or FNB

Time Frame

At 30 minutes

Title

Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 60 mins after either an ACB or FNB

Time Frame

At 60 minutes

Title

Assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes after the first nerve block.

Time Frame

At 30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults (>18yrs) ASA 1-2 Exclusion Criteria: BMI >30 Allergy to local anesthetics Pre-existing gait disturbance Pre-existing neuropathy

Facility Information:

Facility Name

St. Luke's Roosevelt Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10025

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block for Quadriceps Strength and Fall-risk

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