Ultrasound Guidance Versus Electrical Stimulation for Perineural Catheter Insertion

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877266
• Other study ID #: US vs. NS Perineural Catheter
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2009
• Last updated: April 6, 2009
• Start date: August 2007
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
United States	UCSD Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No