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Comparison of Safety And Efficacy of Neuraxial Anesthesia, Palpation Versus Ultrasound

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ClinicalTrials.gov Identifier: NCT01322126
Recruitment Status : Unknown
Verified March 2011 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : March 24, 2011
Last Update Posted : April 11, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Regional Anesthesia Device: ultrasound probe

Detailed Description:

It is known that ultrasound can be useful to assist placement of epidural analgesia among pregnant women.extenseve research on the usefulness of ultrasound imaging to facilitate the placement of neuraxial anesthesia in pregnant have been done.The potential advantages of successful placement among non-pregnant patients include increases the safety and comfort.

In our study all patients schedueld to receive an nueraxial anesthesia for non-obstetric surgery will be included.The investigator will request permission from the Helsinki committee of hadassah university hospital.Patients will be requesting for surgery and will be randomized to one of two study groups.One group will be passed neuraxial anesthesia on the standart technique and the secound group will be passed neuraxial anesthesia with the help of ultrasound.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Safety And Efficacy of Neyraxial Anesthesia,Palpation Versus Ultrasound
Study Start Date : April 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ultrasound ,without ultrasound
ultrasound group will be passed the neuraxial anesthesia with ultrasound,the secoud group will be passed the neuraxial anesthesia without ultrasound .
Device: ultrasound probe
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.

Outcome Measures

Primary Outcome Measures :
  1. Number of epidural attempts made to succeed for placing epidural needle and catheter in epidural space [ Time Frame: one year ]
    Each attempt at placing epidural needle in epidural space will be recorded. Total number of attempts will be recorded

Secondary Outcome Measures :
  1. patient satisfaction as measured by VAS (0=not satisfied, 10 = most satisfied) [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • all patients scheduled for neuraxial anesthesia

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322126

Contact: Fayez T Saifi, MD 00972508946127 saififayez@gmail.com
Contact: Hadas Lemberg, PhD 0097226777572 lhadas@hadassah.org.il

Hadassah Medical Organization Not yet recruiting
Jerusalem 91120, Israel, P.O.BOX 12000
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Fayez T Saifi, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Fayez T Saifi, MD Hadassah Medical Organization
More Information

Responsible Party: Dr Saifi Fayez, Hadassah Medical Organization, Israel Ministry of Health
ClinicalTrials.gov Identifier: NCT01322126     History of Changes
Other Study ID Numbers: 00710-HMO-CTIL
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs