Ultrasound Guidance Versus Electrical Stimulation for Perineural Catheter Insertion

NCT ID: NCT00877266

Last Updated: 2009-04-07

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

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-02-28

Brief Summary

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This research study is to determine the relative times for perineural catheter placement with the use of ultrasound versus electrical stimulation. The perineural catheter is placed next to the nerves through which local anesthetic is placed to provide pain control following surgery. This study may determine if one method is associated with increased success rate and patient comfort.

Detailed Description

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Primary Specific Aim: To determine if the relative times for perineural catheter placement with the use of ultrasound versus electrical stimulation.

Hypothesis: Compared with the use of electrical stimulation, the use of ultrasound guidance when inserting a perineural catheter is associated with a decreased time of placement.

Secondary Specific Aim: To determine if other possible benefits of perineural catheter placement associated with the use of ultrasound guidance versus electrical stimulation.

Hypothesis: Compared with the use of electrical stimulation, the use of ultrasound guidance when inserting a perineural catheter is associated with an increased surgical block success rate and catheter-placement success rate, as well as decreased patient discomfort and incidence of venous puncture.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. Ultrasound

Ultrasound is randomly chosen by use of a computer program. The time for catheter placement will begin with the ultrasound probe touches the patient. Patients will be asked their discomfort on a 0-10 scale (0=no discomfort and 10=worst discomfort imaginable) and will be called the next day by the research staff.

Group Type ACTIVE_COMPARATOR

perineural mepivicaine catheter placed via ultrasound or electrical stimulation

Intervention Type PROCEDURE

Patients will be randomized to one of two groups: catheter placement via ultrasound or nerve stimulation. Placement of the catheter will be timed by research staff and discomfort level asked after placement of catheter. If the catheter is not placed by the randomized method within 15 minutes, the practitioner my switch to the alternate method. Patients will be called the morning after surgery by research staff to assess discomfort levels.

2. Electrical Stimulation

Nerve Stimulation (electrical stimulation) is randomly chosen using a computer program. Time of placement begins when the catheter-placement first touches the patient. After catheter placement patient is asked their discomfort on a 0-10 scale (0=no discomfort and 10=worst discomfort imaginable) and called the day after surgery by the research staff.

Group Type ACTIVE_COMPARATOR

perineural mepivicaine catheter placed via ultrasound or electrical stimulation

Intervention Type PROCEDURE

Patients will be randomized to one of two groups: catheter placement via ultrasound or nerve stimulation. Placement of the catheter will be timed by research staff and discomfort level asked after placement of catheter. If the catheter is not placed by the randomized method within 15 minutes, the practitioner my switch to the alternate method. Patients will be called the morning after surgery by research staff to assess discomfort levels.

Interventions

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perineural mepivicaine catheter placed via ultrasound or electrical stimulation

Patients will be randomized to one of two groups: catheter placement via ultrasound or nerve stimulation. Placement of the catheter will be timed by research staff and discomfort level asked after placement of catheter. If the catheter is not placed by the randomized method within 15 minutes, the practitioner my switch to the alternate method. Patients will be called the morning after surgery by research staff to assess discomfort levels.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* undergoing surgery with a planned perineural catheter for postoperative analgesia
* catheter in the interscalene, infraclavicular, popliteal, or femoral anatomic location
* age 18 years or older

Exclusion Criteria

* pregnancy
* inability to communicate with the investigators and hospital staff
* incarceration
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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US vs. NS Perineural Catheter

Identifier Type: -

Identifier Source: org_study_id

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