NCT01322126

Brief Summary

The purpose of this study is to determine whether use of the ultrasound to locate the epidural space and assist with performing neuraxial anesthesia will decrease numbers of the attempts required for successful placement of epidural catheter.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

March 7, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 11, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

March 7, 2011

Last Update Submit

April 7, 2011

Conditions

Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Number of epidural attempts made to succeed for placing epidural needle and catheter in epidural space

    Each attempt at placing epidural needle in epidural space will be recorded. Total number of attempts will be recorded

    one year

Secondary Outcomes (1)

  • patient satisfaction as measured by VAS (0=not satisfied, 10 = most satisfied)

    one year

Study Arms (1)

ultrasound ,without ultrasound

EXPERIMENTAL

ultrasound group will be passed the neuraxial anesthesia with ultrasound,the secoud group will be passed the neuraxial anesthesia without ultrasound .

Device: ultrasound probe

Interventions

ultrasound probeDEVICE

we will compare two technique of neuraxial anesthesia;one group will be passed neuraxial anesthesia with the intervention the ultrasound and the other group without the intervention of the ultrasound.

ultrasound ,without ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients scheduled for neuraxial anesthesia

You may not qualify if:

  • previous spine surgery
  • contraindication for neuraxial anesthesia
  • refusing to sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, P.O.BOX 12000, Israel

Location

Study Officials

  • Fayez T Saifi, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fayez T Saifi, MD

CONTACT

00972508946127saififayez@gmail.com

Hadas Lemberg, PhD

CONTACT

0097226777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 24, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 11, 2011

Record last verified: 2011-03

Locations

IL(1)