Effects of Catheter Tip Location Relative to the Femoral Nerve on Sensory and Motor Function
This study has been completed.
Sponsor:
University of California, San Diego
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
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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
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 June 18, 2013