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Clinical Trials/NCT01263249
NCT01263249CompletedPhase 4

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

University of California, San Diego1 site in 1 country19 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
19
Locations
1
Primary Endpoint
Quadriceps femoris muscle strength

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

  • •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

Arms & Interventions

Catheter Anterior to Femoral Nerve

Active Comparator

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.

Intervention: Catheter Anterior to the Femoral Nerve (Procedure)

Catheter Posterior to Femoral Nerve

Active Comparator

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.

Intervention: Catheter Posterior to the Femoral Nerve (Procedure)

Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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