NCT00877266

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Aug 2007

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

1.5 years

First QC Date

April 3, 2009

Last Update Submit

April 6, 2009

Conditions

Postoperative Pain

Keywords

catheterultrasound guidancenerve stimulationelectrical stimulationnerve blockUCSDtimed placementsurgeryCatheter Placement Time

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measurement will be the time of placement for a perineural catheter using either ultrasound-guided method or electrical stimulation method.

    30 minutes

Secondary Outcomes (1)

  • Pain and discomfort as assessed by a 0-10 scale (0=no pain/discomfort and 10=worst pain/discomfort imaginable) by the research coordinator.

    After catheter placement and Postoperative day 1

Study Arms (2)

1. Ultrasound

ACTIVE COMPARATOR

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

2. Electrical Stimulation

ACTIVE COMPARATOR

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

Interventions

perineural mepivicaine catheter placed via ultrasound or electrical stimulationPROCEDURE

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.

1. Ultrasound2. Electrical Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • inability to communicate with the investigators and hospital staff
  • incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • Brian M Ilfeld, M.D., M.S.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 7, 2009

Study Start

August 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 7, 2009

Record last verified: 2009-04

Locations

US(1)