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

Phase 4

Completed

• Conditions: Continuous Femoral Nerve Blocks in Healthy Volunteers
• Interventions: Procedure: Catheter Anterior to the Femoral Nerve; Procedure: Catheter Posterior to the Femoral Nerve

• Registration Number: NCT01263249
• Lead Sponsor: University of California, San Diego

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-20
• Primary Completion: 2011-04
• Status Verified: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-13
• Last Update Posted: 2011-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter Anterior to Femoral Nerve	Catheter Anterior to the 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.
Catheter Posterior to Femoral Nerve	Catheter Posterior to the 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.

Primary Outcome Measures

Name	Time	Method
Quadriceps femoris muscle strength	percentage of baseline muscle strength six hours after infusion initiation	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

Trial Locations

Locations (1)

UCSD Medical Center, Hillcrest; 🇺🇸 San Diego, California, United States