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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01322126
First received: March 7, 2011
Last updated: April 7, 2011
Last verified: March 2011
  Purpose

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 Intervention
Regional Anesthesia
Device: ultrasound probe

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of Safety And Efficacy of Neyraxial Anesthesia,Palpation Versus Ultrasound

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Number of epidural attempts made to succeed for placing epidural needle and catheter in epidural space [ Time Frame: one year ] [ Designated as safety issue: No ]
    Each attempt at placing epidural needle in epidural space will be recorded. Total number of attempts will be recorded


Secondary Outcome Measures:
  • patient satisfaction as measured by VAS (0=not satisfied, 10 = most satisfied) [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322126

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

Locations
Israel
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
Investigators
Principal Investigator: Fayez T Saifi, MD Hadassah Medical Organization
  More Information

No publications provided

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
Study First Received: March 7, 2011
Last Updated: April 7, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014