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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Jeff Gadsden, St. Luke's-Roosevelt Hospital Center

ClinicalTrials.gov Identifier:

NCT01655277

First received: July 30, 2012

Last updated: NA

Last verified: July 2012

History: No changes posted

Tracking Information
First Received Date ^ICMJE	July 30, 2012
Last Updated Date	July 30, 2012
Start Date ^ICMJE	February 2012
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 30, 2012)	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 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: July 30, 2012)	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 ] [ Designated as safety issue: Yes ] 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 ] [ Designated as safety issue: Yes ] 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 ] [ Designated as safety issue: Yes ] Assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes after the first nerve block. [ Time Frame: At 30 minutes ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block for Quadriceps Strength and Fall-risk
Official Title ^ICMJE	The Effects of Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block on Quadriceps Strength and Fall-risk: a Blinded Randomized Trial of Volunteers
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Quadriceps Muscle Weakness Adductor Muscle Weakness Fall Risk
Intervention ^ICMJE	Procedure: Ultrasound Guided Adductor Canal Block Procedure: Ultrasound Guided Femoral Nerve Block
Study Arm (s)	Experimental: Adductor Canal block first 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. Interventions: Procedure: Ultrasound Guided Adductor Canal Block Procedure: Ultrasound Guided Femoral Nerve Block Experimental: Femoral nerve block first 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. Interventions: Procedure: Ultrasound Guided Adductor Canal Block Procedure: Ultrasound Guided Femoral Nerve Block
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	16
Completion Date	June 2012
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Adults (>18yrs) ASA 1-2 Exclusion Criteria: BMI >30 Allergy to local anesthetics Pre-existing gait disturbance Pre-existing neuropathy
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01655277
Other Study ID Numbers ^ICMJE	11-202
Has Data Monitoring Committee
Responsible Party	Jeff Gadsden, St. Luke's-Roosevelt Hospital Center
Study Sponsor ^ICMJE	St. Luke's-Roosevelt Hospital Center
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	St. Luke's-Roosevelt Hospital Center
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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