Effects of Catheter Tip Location Relative to the Femoral Nerve on Sensory and Motor Function

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01263249
First received: December 16, 2010
Last updated: June 13, 2011
Last verified: June 2011
  Purpose

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
Continuous Femoral Nerve Blocks in Healthy Volunteers
Procedure: Catheter Anterior to the Femoral Nerve
Procedure: Catheter Posterior to the Femoral Nerve
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Femoral Nerve Blocks: Effects of Catheter Tip Location Relative to the Femoral Nerve 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: percentage of baseline muscle strength six hours after infusion initiation ] [ Designated as safety issue: No ]
    The primary end point will be the quadriceps femoris maximum voluntary isometric contraction (MVIC) expressed as a percentage of the pre-ropivacaine MVIC: post / pre x 100; with the two sides of each subject compared with each other


Estimated Enrollment: 19
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Catheter Anterior to Femoral Nerve
Each subject will have one lower extremity (Right or Left) randomized to receive a perinural catheter, placed anterior to the femoral nerve, with a continuous infusion of local anesthetic and then the outcomes will be measured.
Procedure: Catheter Anterior to the Femoral Nerve
Extremity randomized to Anterior Placement will be given a peripheral nerve block with the catheter placed just anterior to the femoral nerve. 4cc of Ropivicaine will be administered continuously every hour by a pain pain pump and the outcome measures will be tested.
Active Comparator: Catheter Posterior to Femoral Nerve
Each subject will have the opposite lower extremity (Right or Left) randomized to receive a perinural catheter, placed posterior to the femoral nerve, with a continuous infusion of local anesthetic and then the outcomes will be measured.
Procedure: Catheter Posterior to the Femoral Nerve
Extremity randomized to Posterior Placement will be given a peripheral nerve block with the catheter placed just posterior to the femoral nerve. 4cc of Ropivicaine will be administered continuously every hour by a pain pain pump and the outcome measures will be tested.

Detailed Description:

Specific Aim: Research study to test the hypothesis that differing the location of the perineural catheter tip during a continuous femoral nerve block (anterior vs. posterior) impacts quadriceps muscle strength. These results will help define the optimal perineural catheter tip location relative to the femoral nerve used for continuous peripheral nerve blocks and help guide both clinical care and 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 over
  • Willing to have bilateral femoral perineural catheters placed with a subsequent ropivacaine infusion and motor/sensory testing for 6 hours, requiring an overnight stay 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 within the previous 4 weeks
  • any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
  • body mass index > 30 kg/m2
  • 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: NCT01263249

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 Ilfeld, M.D., M.S., University of California, San Diego, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT01263249     History of Changes
Other Study ID Numbers: Volunteer Anterior Posterior
Study First Received: December 16, 2010
Last Updated: June 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Femoral
Nerve Block
Anterior
Posterior
Continuous Infusion
Perineural Catheter
Volunteer
Lower Extremity Nerve Blocks

ClinicalTrials.gov processed this record on September 18, 2014