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Completed

NCT Number: NCT00877266

Ultrasound Guidance Versus Electrical Stimulation for Perineural Catheter Insertion

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCSD Medical Center

San Diego, California, 92103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perineural mepivicaine catheter placed via ultrasound or electrical stimulation

Procedure

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.

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.

    Time frame: 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.

    Time frame: After catheter placement and Postoperative day 1

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 7, 2009
Registry last updated
Apr 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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