Ultrasound Guidance Versus Electrical Stimulation for Perineural Catheter Insertion

April 6, 2009 updated by: University of California, San Diego

Ultrasound Guidance vs. Electrical Stimulation for Perineural Catheter Insertion: A Randomized, Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UCSD Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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.
Active Comparator: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measurement will be the time of placement for a perineural catheter using either ultrasound-guided method or electrical stimulation method.
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain and discomfort as assessed by a 0-10 scale (0=no pain/discomfort and 10=worst pain/discomfort imaginable) by the research coordinator.
Time Frame: After catheter placement and Postoperative day 1
After catheter placement and Postoperative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Estimate)

April 7, 2009

Last Update Submitted That Met QC Criteria

April 6, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US vs. NS Perineural Catheter

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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