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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Continuous Femoral Nerve Blocks: Effects of Catheter Tip Location Relative to the Femoral Nerve on Sensory and Motor Function

Conditions
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Continuous Femoral Nerve Blocks in Healthy Volunteers

Intervention / Treatment
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* Procedure: Catheter Anterior to the Femoral Nerve
* Procedure: Catheter Posterior to the Femoral Nerve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Catheter Anterior to Femoral Nerve<br>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<br>* 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.<br>|
| Active Comparator: Catheter Posterior to Femoral Nerve<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps femoris muscle strength | 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 | percentage of baseline muscle strength six hours after infusion initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral, Nerve Block, Anterior, Posterior, Continuous Infusion, Perineural Catheter, Volunteer, Lower Extremity Nerve Blocks