- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655277
Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block for Quadriceps Strength and Fall-risk
July 30, 2012 updated by: Jeff Gadsden, St. Luke's-Roosevelt Hospital Center
The Effects of Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block on Quadriceps Strength and Fall-risk: a Blinded Randomized Trial of Volunteers
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10025
- St. Luke's Roosevelt Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults (>18yrs)
- ASA 1-2
Exclusion Criteria:
- BMI >30
- Allergy to local anesthetics
- Pre-existing gait disturbance
- Pre-existing neuropathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
At 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
At 60 minutes
|
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
|
At 30 minutes
|
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
|
At 60 minutes
|
Assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes after the first nerve block.
Time Frame: At 30 minutes
|
At 30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
July 30, 2012
First Submitted That Met QC Criteria
July 30, 2012
First Posted (Estimate)
August 1, 2012
Study Record Updates
Last Update Posted (Estimate)
August 1, 2012
Last Update Submitted That Met QC Criteria
July 30, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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