NCT01655277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

4 months

First QC Date

July 30, 2012

Last Update Submit

July 30, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

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

    At 30 minutes

Secondary Outcomes (4)

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

    At 60 minutes

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

    At 30 minutes

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

    At 60 minutes

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

    At 30 minutes

Study Arms (2)

Adductor Canal block first

EXPERIMENTAL

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 BlockProcedure: Ultrasound Guided Femoral Nerve Block

Femoral nerve block first

EXPERIMENTAL

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 BlockProcedure: Ultrasound Guided Femoral Nerve Block

Interventions

Adductor Canal block firstFemoral nerve block first
Adductor Canal block firstFemoral nerve block first

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (\>18yrs)
  • ASA 1-2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's Roosevelt Hospital

New York, New York, 10025, United States

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Regional Anesthesia

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 1, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations