Regional AnesthesiaNCT01322126
Comparison of Safety And Efficacy of Neuraxial Anesthesia, Palpation Versus Ultrasound
A study testing ultrasound probe in people with Regional Anesthesia, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anesthesia
- What is being tested?
- ultrasound probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients scheduled for neuraxial anesthesia
Who cannot join
- previous spine surgery
- contraindication for neuraxial anesthesia
- refusing to sign the consent form
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, P.O.BOX 12000
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Comparison of Safety And Efficacy of Neyraxial Anesthesia,Palpation Versus Ultrasound
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.
Read the 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.
- Conditions
- Regional Anesthesia
- Being tested
- ultrasound probe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Device: ultrasound probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (1)
patient satisfaction as measured by VAS (0=not satisfied, 10 = most satisfied)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Fayez T Saifi, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322126
- Sponsor's protocol ID
- 00710-HMO-CTIL
- Status last verified
- Mar 2011
- First submitted
- 7 Mar 2011
- Last updated
- 11 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety And Efficacy of Neyraxial Anesthesia,Palpation Versus Ultrasound
- ClinicalTrials.gov ID
- NCT01322126
- Acronym / sponsor ID
- 00710-HMO-CTIL
- Conditions
- Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound ,without ultrasound | Experimental | Device: ultrasound probeultrasound group will be passed the neuraxial anesthesia with ultrasound,the secoud group will be passed the neuraxial anesthesia without ultrasound . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients scheduled for neuraxial anesthesia
Key exclusion criteria (3 listed)
- previous spine surgery
- contraindication for neuraxial anesthesia
- refusing to sign the consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound probewe 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. | Device | ultrasound ,without ultrasound |
Primary outcome
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
1 secondary outcome
patient satisfaction as measured by VAS (0=not satisfied, 10 = most satisfied)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fayez T Saifi, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound probe in people with Regional Anesthesia, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fayez T Saifi, MD (00972508946127, saififayez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of epidural attempts made to succeed for placing epidural needle and catheter in epidural space (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2011.