Completed

NCT Number: NCT01263249

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

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.

Completed

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Key information

Conditions

Continuous Femoral Nerve Blocks in Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCSD Medical Center, Hillcrest

San Diego, California, 92103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter Anterior to the Femoral Nerve

Procedure

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.

Catheter Posterior to the Femoral Nerve

Procedure

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.

Primary outcomes

Quadriceps femoris muscle strength

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Dec 20, 2010
Registry last updated: Jun 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.