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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01655277
Other study ID # 11-202
Secondary ID
Status Completed
Phase Phase 4
First received July 30, 2012
Last updated July 30, 2012
Start date February 2012
Est. completion date June 2012

Study information

Verified date July 2012
Source St. Luke's-Roosevelt Hospital Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Adults (>18yrs)

- ASA 1-2

Exclusion Criteria:

- BMI >30

- Allergy to local anesthetics

- Pre-existing gait disturbance

- Pre-existing neuropathy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Procedure:
Ultrasound Guided Adductor Canal Block

Ultrasound Guided Femoral Nerve Block


Locations

Country Name City State
United States St. Luke's Roosevelt Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB At 30 minutes Yes
Secondary Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 60 mins after either an ACB or FNB At 60 minutes Yes
Secondary Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 30 mins after either an ACB or FNB At 30 minutes Yes
Secondary Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 60 mins after either an ACB or FNB At 60 minutes Yes
Secondary Assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes after the first nerve block. At 30 minutes Yes
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