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Continuous Femoral Nerve Blocks: Relative Effects of Basal Infusion and Bolus Doses on Sensory and Motor Function

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ClinicalTrials.gov Identifier: NCT01144559
Recruitment Status : Completed
First Posted : June 15, 2010
Last Update Posted : November 1, 2010
Sponsor:
Information provided by:
University of California, San Diego

Study Description
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Brief Summary:
This is a research study to determine if the way local anesthetic- or numbing medication- is delivered through a tiny tube next to the nerves that go to the thigh affects the strength and sensation in the thigh.

Condition or disease Intervention/treatment Phase
Nerve Block Procedure: Continuous Infusion Procedure: Bolus Administered Phase 4

Detailed Description:
Specific Aim: Research study to test the null hypothesis that differing the delivery method (continuous basal infusion vs. repeated bolus doses) but providing an equal total dose of Ropivacaine has no impact on quadriceps muscle strength. These results will help define the optimal delivery method of local anesthetic used for continuous peripheral nerve blocks and help guide future research in this clinically relevant area.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Femoral Nerve Blocks: Relative Effects of Basal Infusion and Bolus Doses on Sensory and Motor Function
Study Start Date : June 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Continuous Infusion
Each subject will have one lower extremity (Right or Left) randomized to receive a perineural catheter with a continuous infusion of local anesthetic and then the outcomes will be measured.
 Procedure: Continuous Infusion
Extremity randomized continuous infusion will be given a peripheral nerve block and 5cc of Ropivacaine will be administered continuously every hour by a pain pump. Outcome measures will be tested.
Active Comparator: Bolus Administration
The opposite lower extremity (right or left) will be randomized to receive a perineural catheter with the local anesthetic being delivered via a bolus as opposed to continuous as is the case with their other extremity. The outcome measures will then be assessed as described.
 Procedure: Bolus Administered
Extremity randomized continuous infusion will be given a peripheral nerve block and 5cc of Ropivacaine will be administered using a bolus every hour by a pain pump. Outcome measures will be tested.


Outcome Measures
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Primary Outcome Measures :
  1. Quadriceps Femoris Muscle Strength [ Time Frame: Every Hour for 14 hours ]
    The primary end point will be the quadriceps femoris maximum voluntary isometric contraction (MVIC) expressed as percentage of the pre-ropivacaine MVIC: post/pre x 100; with the two sides of each subject compared with each other.

  2. Quadriceps Femoris Muscle Strength [ Time Frame: Hour 22 ]
    The primary end point will be the quadriceps femoris maximum voluntary isometric contraction (MVIC) expressed as percentage of the pre-ropivacaine MVIC: post/pre x 100; with the two sides of each subject compared with each other.


Secondary Outcome Measures :
  1. Muscle Strength [ Time Frame: Every Hour for 14 hours ]
    This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position.

  2. Sensory Level [ Time Frame: Every Hour for 14 hours ]
    Evaluated in the seated position, using Transcutaneous Electrical Stimulation (TES)in the same manner as outlined in the current anesthesia literature. The current will be increased from 0mA until the subject identifies sensation at which time the current is recorded as the TES value and the nerve stimulator is turned off.

  3. Muscle Strength [ Time Frame: Hour 22 ]
    This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position.

  4. Sensory Level [ Time Frame: Hour 22 ]
    Evaluated in the seated position, using Transcutaneous Electrical Stimulation (TES)in the same manner as outlined in the current anesthesia literature. The current will be increased from 0mA until the subject identifies sensation at which time the current is recorded as the TES value and the nerve stimulator is turned off.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • willing to have bilateral femoral perineural catheters place with a subsequent ropivacaine infusion and motor/sensory testing for 9 hours
  • willing to stay overnight in the UCSD GCRC/CTRI to allow dissipation of local anesthetic infusion effects by the following morning.

Exclusion Criteria:

  • current daily analgesic use
  • opioid use with in the previous 4 weeks
  • any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
  • pregnancy
  • incarceration
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144559


Locations
United States, California
UCSD Medical Center, Hillcrest
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego
More Information
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Responsible Party: Brian M. Ilfeld, M.D., M.S./Principal Investigator, University of California, San Diego, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT01144559     History of Changes
Other Study ID Numbers: Femoral Sensory and Motor
First Posted: June 15, 2010    Key Record Dates
Last Update Posted: November 1, 2010
Last Verified: October 2010

Keywords provided by University of California, San Diego:
Femoral
Nerve Block
Bolus
Continuous Infusion
 UCSD
Perineural Catheter
Volunteer
lower extremity nerve blocks