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Continuous Femoral Nerve Blocks: Relative Effects of Basal Infusion and Bolus Doses on Sensory and Motor Function

NCT ID: NCT01144559

Last Updated: 2010-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-09-30

Brief Summary

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This is a research study 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 null hypothesis that differing the delivery method (continuous basal infusion vs. repeated bolus doses) but providing an equal total dose of Ropivacaine has no impact on quadriceps muscle strength. These results will help define the optimal delivery method of local anesthetic used for continuous peripheral nerve blocks and help guide future research in this clinically relevant area.

Conditions

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Nerve Block

Keywords

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Femoral Nerve Block Bolus Continuous Infusion UCSD Perineural Catheter Volunteer lower extremity nerve blocks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Continuous Infusion

Each subject will have one lower extremity (Right or Left) randomized to receive a perineural catheter with a continuous infusion of local anesthetic and then the outcomes will be measured.

Group Type ACTIVE_COMPARATOR

Continuous Infusion

Intervention Type PROCEDURE

Extremity randomized continuous infusion will be given a peripheral nerve block and 5cc of Ropivacaine will be administered continuously every hour by a pain pump. Outcome measures will be tested.

Bolus Administration

The opposite lower extremity (right or left) will be randomized to receive a perineural catheter with the local anesthetic being delivered via a bolus as opposed to continuous as is the case with their other extremity. The outcome measures will then be assessed as described.

Group Type ACTIVE_COMPARATOR

Bolus Administered

Intervention Type PROCEDURE

Extremity randomized continuous infusion will be given a peripheral nerve block and 5cc of Ropivacaine will be administered using a bolus every hour by a pain pump. Outcome measures will be tested.

Interventions

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Continuous Infusion

Extremity randomized continuous infusion will be given a peripheral nerve block and 5cc of Ropivacaine will be administered continuously every hour by a pain pump. Outcome measures will be tested.

Intervention Type PROCEDURE

Bolus Administered

Extremity randomized continuous infusion will be given a peripheral nerve block and 5cc of Ropivacaine will be administered using a bolus every hour by a pain pump. Outcome measures will be tested.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* willing to have bilateral femoral perineural catheters place with a subsequent ropivacaine infusion and motor/sensory testing for 9 hours
* willing to stay overnight 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 with in the previous 4 weeks
* any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
* pregnancy
* incarceration
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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University of California, San Diego, Department of Anesthesiology

Principal Investigators

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Brian M Ilfeld, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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UCSD Medical Center, Hillcrest

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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Femoral Sensory and Motor

Identifier Type: -

Identifier Source: org_study_id