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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01144559
First received: June 14, 2010
Last updated: October 29, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Nerve Block
Procedure: Continuous Infusion
Procedure: Bolus Administered
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Quadriceps Femoris Muscle Strength [ Time Frame: Every Hour for 14 hours ] [ Designated as safety issue: No ]
    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.

  • Quadriceps Femoris Muscle Strength [ Time Frame: Hour 22 ] [ Designated as safety issue: No ]
    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:
  • Muscle Strength [ Time Frame: Every Hour for 14 hours ] [ Designated as safety issue: No ]
    This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position.

  • Sensory Level [ Time Frame: Every Hour for 14 hours ] [ Designated as safety issue: No ]
    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.

  • Muscle Strength [ Time Frame: Hour 22 ] [ Designated as safety issue: No ]
    This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position.

  • Sensory Level [ Time Frame: Hour 22 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 15
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: June 14, 2010
Last Updated: October 29, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014