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

Regional Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01322126
• Other study ID #: 00710-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: March 7, 2011
• Last updated: April 7, 2011
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: March 2011
• Source: Hadassah Medical Organization
• Contact: Fayez T Saifi, MD
• Phone: 00972508946127
• Email: saififayez[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients scheduled for neuraxial anesthesia

Exclusion Criteria:

• previous spine surgery

• contraindication for neuraxial anesthesia

• refusing to sign the consent form

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Regional Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem 91120

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	patient satisfaction as measured by VAS (0=not satisfied, 10 = most satisfied)		one year	No