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Comparison of Two Anatomic Landmarks With Ultrasonography in Spinal Anesthesia

Primary Purpose

Arthropathy of Knee

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ultrasonography
Sponsored by
Diskapi Yildirim Beyazit Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Arthropathy of Knee focused on measuring spinal anesthesia, ultrasonography, anatomical landmark

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • knee arthroscopic surgery

Exclusion Criteria:

  • BMI>30
  • anatomical anomaly of vertebrae

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    spinal anesthesia for knee arthroscopy

    Arm Description

    The intervention is spinal anesthesia. Tenth rib line or Tuffier's line will be examined as application landmarks by ultrasonography for spinal anesthesia.

    Outcomes

    Primary Outcome Measures

    success of estimation the correct vertebral space
    Independently, first anesthesist will determine the spinal anesthesia application point (intervertebral space) according to Tuffier's line and second anesthesist will determine it by ultrasonography. And third anesthesist will compare the accuracy of first determination.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 6, 2014
    Last Updated
    August 4, 2015
    Sponsor
    Diskapi Yildirim Beyazit Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02330185
    Brief Title
    Comparison of Two Anatomic Landmarks With Ultrasonography in Spinal Anesthesia
    Official Title
    Phase IV Study of Landmarks for Spinal Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Diskapi Yildirim Beyazit Education and Research Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The most used anatomical landmark for application of spinal anesthesia is Tuffier's line. Other alternative landmark is tenth rib. However there is no trial that compare these landmarks based on using ultrasonography.
    Detailed Description
    The investigators aim to compare two landmarks (Tuffier's line and tenth rib line) for accuracy by using ultrasonography. 40 patients will be included in each groups. all of them will be assessed by ultrasonography during application of spinal anesthesia. And the investigators will examine the percentage of successful estimation of correct vertebral space.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthropathy of Knee
    Keywords
    spinal anesthesia, ultrasonography, anatomical landmark

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    N/A
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    spinal anesthesia for knee arthroscopy
    Arm Type
    Experimental
    Arm Description
    The intervention is spinal anesthesia. Tenth rib line or Tuffier's line will be examined as application landmarks by ultrasonography for spinal anesthesia.
    Intervention Type
    Device
    Intervention Name(s)
    ultrasonography
    Intervention Description
    spinal anesthesia guided with ultrasonography
    Primary Outcome Measure Information:
    Title
    success of estimation the correct vertebral space
    Description
    Independently, first anesthesist will determine the spinal anesthesia application point (intervertebral space) according to Tuffier's line and second anesthesist will determine it by ultrasonography. And third anesthesist will compare the accuracy of first determination.
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: knee arthroscopic surgery Exclusion Criteria: BMI>30 anatomical anomaly of vertebrae
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    dilek yazıcıoğlu
    Organizational Affiliation
    anesthesiology and reanimation
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15023107
    Citation
    Jung CW, Bahk JH, Lee JH, Lim YJ. The tenth rib line as a new landmark of the lumbar vertebral level during spinal block. Anaesthesia. 2004 Apr;59(4):359-63. doi: 10.1111/j.1365-2044.2004.03657.x.
    Results Reference
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    Comparison of Two Anatomic Landmarks With Ultrasonography in Spinal Anesthesia

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