Ultrasound Guidance Versus Electrical Stimulation for Perineural Catheter Insertion

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: perineural mepivicaine catheter placed via ultrasound or electrical stimulation

• Registration Number: NCT00877266
• Lead Sponsor: University of California, San Diego

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.

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 Timeline

• Study Start: 2007-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-04
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-06
• Last Update Submitted: 2009-04-06
• Study First Posted: 2009-04-07
• Last Update Posted: 2009-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Ultrasound	perineural mepivicaine catheter placed via ultrasound or electrical stimulation	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.
2. Electrical Stimulation	perineural mepivicaine catheter placed via ultrasound or 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 San Diego, California, United States