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CompletedNCT01263249Updated Jun 14, 2011

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

A Phase 4 interventional study of Catheter Anterior to the Femoral Nerve and Catheter Posterior to the Femoral Nerve in Continuous Femoral Nerve Blocks in Healthy Volunteers, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-14.

Sponsored by University of California, San Diego · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Continuous Femoral Nerve Blocks in Healthy Volunteers

Keywords

  • Femoral
  • Nerve Block
  • Anterior
  • Posterior
  • Continuous Infusion
  • Perineural Catheter
  • Volunteer
  • Lower Extremity Nerve Blocks
03

In context

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
19 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureCatheter 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.

  • ProcedureCatheter 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: percentage of baseline muscle strength six hours after infusion initiation

07

Study locations

1 site
  • UCSD Medical Center, Hillcrest
    San Diego, California 92103, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01263249
Lead sponsor
University of California, San Diego
First posted
Dec 20, 2010
Start date
Jan 2010
Primary completion
Apr 2011
Completion
Jun 2011
Last update
Jun 14, 2011

Study contacts

Brian M Ilfeld, M.D., M.S.
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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