Ultrasound Guidance Versus Electrical Stimulation for Perineural Catheter Insertion - Full Text View

Purpose

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.

Condition	Intervention	Phase
Postoperative Pain	Procedure: perineural mepivicaine catheter placed via ultrasound or electrical stimulation	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Ultrasound Guidance vs. Electrical Stimulation for Perineural Catheter Insertion: A Randomized, Controlled Trial

Resource links provided by NLM:

Drug Information available for: Mepivacaine Mepivacaine hydrochloride

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	180
Study Start Date:	August 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877266

Locations

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

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:

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

University of California, San Diego

More Information

No publications provided

Responsible Party:	Brian Ilfeld, M.D., M.S./ Principal Investigator, University of California, San Diego, Department of Anesthesiology
ClinicalTrials.gov Identifier:	NCT00877266 History of Changes
Other Study ID Numbers:	US vs. NS Perineural Catheter
Study First Received:	April 3, 2009
Last Updated:	April 6, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

catheter
ultrasound guidance
nerve stimulation
electrical stimulation
nerve block

UCSD
timed placement
surgery
Catheter Placement Time

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Mepivacaine
Anesthetics, Local
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013