NCT02330185

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

November 6, 2014

Last Update Submit

August 4, 2015

Conditions

Arthropathy of Knee

Keywords

spinal anesthesiaultrasonographyanatomical landmark

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Study Arms (1)

spinal anesthesia for knee arthroscopy

EXPERIMENTAL

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

Device: ultrasonography

Interventions

ultrasonographyDEVICE

spinal anesthesia guided with ultrasonography

spinal anesthesia for knee arthroscopy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • knee arthroscopic surgery

You may not qualify if:

  • BMI\>30
  • anatomical anomaly of vertebrae

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 15023107BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • dilek yazıcıoğlu

    anesthesiology and reanimation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phase IV Study of Landmarks for Spinal Anesthesia

Study Record Dates

First Submitted

November 6, 2014

First Posted

January 1, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 5, 2015

Record last verified: 2015-08