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
  Purpose

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.


Condition Intervention Phase
Quadriceps Muscle Weakness
Adductor Muscle Weakness
Fall Risk
Procedure: Ultrasound Guided Adductor Canal Block
Procedure: Ultrasound Guided Femoral Nerve Block
Phase 4

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

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Procedure: Ultrasound Guided Adductor Canal Block Procedure: Ultrasound Guided Femoral Nerve Block

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults (>18yrs)
  • ASA 1-2

Exclusion Criteria:

  • BMI >30
  • Allergy to local anesthetics
  • Pre-existing gait disturbance
  • Pre-existing neuropathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655277

Locations
United States, New York
St. Luke's Roosevelt Hospital
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: Jeff Gadsden, Director of Regional Anesthesia, St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01655277     History of Changes
Other Study ID Numbers: 11-202
Study First Received: July 30, 2012
Last Updated: July 30, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthenia
Muscle Weakness
Paresis
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014