Clincosm LogoSign in Get a demo

A Comparison of Ultrasound and Nerve Stimulator Techniques for Nerve Localization in Regional Anesthesia

Sponsor
Ochsner Health System (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01221415
Collaborator
(none)
0
Enrollment
1
Location
45
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to compare ultrasound versus nerve stimulator techniques for nerve localization when performing peripheral nerve blocks. Specifically the investigators will be performing Popliteal, Femoral, and Interscalene nerve blocks. The investigators will be looking for differences in 1) time taken to locate the target nerve and inject local anesthetic 2) time from injection of local anesthetic to adequate surgical anesthesia 3) effectiveness of block 4) incidence of vascular puncture 5) incidence of adverse events 6) patient satisfaction.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    After obtaining informed consent, subjects will be randomized to either the ultrasound or nerve stimulator groups as the method for nerve localization prior to peripheral block placement.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    A Comparison of Ultrasound and Nerve Stimulator Techniques for Nerve Localization in Regional Anesthesia
    Study Start Date :
    Jan 1, 2008
    Actual Primary Completion Date :
    Oct 1, 2011
    Actual Study Completion Date :
    Oct 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Interscalene Ultrasound

    Subjects having orthopedic surgery requiring an interscalene peripheral nerve block and randomized to have the ultrasound used to locate the nerve.
    Interscalene Nerve Stimulator

    Subjects having orthopedic surgery requiring an interscalene peripheral nerve block and randomized to have the nerve stimulator used to locate the nerve.
    Popliteal Ultrasound

    Subjects having orthopedic surgery requiring an popliteal peripheral nerve block and randomized to have the ultrasound used to locate the nerve.
    Popliteal Nerve Stimulator

    Subjects having orthopedic surgery requiring an popliteal peripheral nerve block and randomized to have the nerve stimulator used to locate the nerve.
    Femoral Ultrasound

    Subjects having orthopedic surgery requiring an femoral peripheral nerve block and randomized to have the ultrasound used to locate the nerve.
    Femoral Nerve Stimulator

    Subjects having orthopedic surgery requiring an femoral peripheral nerve block and randomized to have the nerve stimulator used to locate the nerve.

    Outcome Measures

    Primary Outcome Measures

    1. time from injection of local anesthetic to adequate surgical anesthesia [within the first 45 minutes after injection of local anesthestic]

    Secondary Outcome Measures

    1. effectiveness of block [within 1 hour of injection]

    2. time taken to locate the target nerve and inject local anesthetic [within 45 minutes prior to injection]

    3. incidence of vascular puncture [within 30 minutes of injection]

    4. incidence of adverse events [within 2 weeks of the day of surgery]

    5. patient satisfaction [within 2 weeks of the date of surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • American Society of Anesthesiologists (ASA) Physical status I-III

    • Arthroscopic knee surgery or Lower leg/foot surgery as well as shoulder arthroscopy

    • Outpatient status

    • Patient preference for a regional anesthetic

    • Subjects should be capable of giving informed consent

    Exclusion Criteria:

    • Allergy to:

    • Local anesthetics

    • Hydromorphone

    • Propofol

    • Midazolam

    • Patient refusal

    • Infection at the injection site

    • Peripheral Neuropathy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ochsner Clinic Foundation New Orleans Louisiana United States 70121

    Sponsors and Collaborators

    • Ochsner Health System

    Investigators

    • Principal Investigator: Leslie Thomas, MD, Ochsner Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leslie Thomas, Anesthesiologist, Ochsner Health System
    ClinicalTrials.gov Identifier:
    NCT01221415
    Other Study ID Numbers:
    • 2007.127.A
    • 2007.127.A
    First Posted:
    Oct 15, 2010
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022

    Study Results

    No Results Posted as of Apr 27, 2022