Epidural PlacementNCT01686243
Real-time Ultrasound-guided Paramedian Epidural Access: Evaluation of a Novel In-plane Transverse View Technique
A study testing epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono) and standard epidural placement in people with Epidural Placement, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Epidural Placement
- What is being tested?
- epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono) and standard epidural placement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 25 Nov 2016
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients 30 to 80 years old at time of surgery.
- Patients in whom epidural anesthesia is planned to be used as the for surgery " Surgical epidural"
Who cannot join
- Current or recent drug abuse (within past 6 months).
- Allergy to local anesthetics
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk TuohySono"
The investigators believe that this new technique is helpful to get the best anatomic landmark for epidural catheter placement using the real-time ultrasound.
Read more
Measurable outcomes:
- Block performance time.
- Block success rate.
- Needle Depth to epidural space
Block success rate will be measured as the rate of cases that will have successful insertion of the epidural catheter using ultrasound guidance and the case is done completely under epidural anesthesia.
All cases that will be converted to general anesthesia will be counted unsuccessful.
Other measurable outcome data that will be collected will include needle depth to the epidural space, and ultrasound measured depth to the lamina
- Conditions
- Epidural Placement
- Being tested
- epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono), standard epidural placement
- Keywords
- epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)Other
Anesthesiologist will place epidural with aid of ultrasound and placement with echogenic 17G Tuohy needles (Pajunk TuohySono)
standard epidural placementOther
Anesthesiologist will place epidural within standard practice, with standard needles.
| Study group | Role | What they receive |
|---|---|---|
| echogenic 17G tuohy needles " Pajunk TuohySono | Experimental | Epidural will be placed with the aid of ultrasound and echogenic 17G Tuohy needles (Pajunk TuohySono). Receives: Other: epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono) |
| standard epidural needles | Placebo comparator | Epidural will be placed in standard practice with standard needles. Receives: Other: standard epidural placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time ultrasound-guided paramedian epidural access:
Block success rate will be measured as the rate of cases that will have succesful insertion of the epidural catheter using ultrasound guidance and the case is done completely under epidural anesthesia. The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk TuohySono"
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startJul 2012
- Primary completion25 Nov 2016
- Study completion25 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidural PlacementStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loran Mounir Solimin, MD, The Cleveland Clinic
- Investigators
- Sherif Zaky, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686243
- Sponsor's protocol ID
- 12-560
- Status last verified
- Apr 2019
- First submitted
- 18 Jul 2012
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Elsharkawy H, Saasouh W, Babazade R, Soliman LM, Horn JL, Zaky S. Real-time Ultrasound-Guided Lumbar Epidural with Transverse Interlaminar View: Evaluation of an In-Plane Technique. Pain Med. 2019 Sep 1;20(9):1750-1755. doi: 10.1093/pm/pnz026.
PubMed 30865772
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Ultrasound-guided Paramedian Epidural Access: Evaluation of a Novel In-plane Transverse View Technique
- ClinicalTrials.gov ID
- NCT01686243
- Acronym / sponsor ID
- 12-560
- Conditions
- Epidural Placement
- Keywords
- epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 25 Nov 2016 (actual)
- Study completion
- 25 Nov 2016 (actual)
- First posted
- 18 Sep 2012 (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 aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk TuohySono"
The investigators believe that this new technique is helpful to get the best anatomic landmark for epidural catheter placement using the real-time ultrasound.
Measurable outcomes:
- Block performance time.
- Block success rate.
- Needle Depth to epidural space
Block success rate will be measured as the rate of cases that will have successful insertion of the epidural catheter using ultrasound guidance and the case is done completely under epidural anesthesia.
All cases that will be converted to general anesthesia will be counted unsuccessful.
Other measurable outcome data that will be collected will include needle depth to the epidural space, and ultrasound measured depth to the lamina
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| echogenic 17G tuohy needles " Pajunk TuohySono | Experimental | Other: epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)Epidural will be placed with the aid of ultrasound and echogenic 17G Tuohy needles (Pajunk TuohySono). |
| standard epidural needles | Placebo comparator | Other: standard epidural placementEpidural will be placed in standard practice with standard needles. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult Patients 30 to 80 years old at time of surgery.
- Patients in whom epidural anesthesia is planned to be used as the for surgery " Surgical epidural"
Key exclusion criteria (3 listed)
- Current or recent drug abuse (within past 6 months).
- Allergy to local anesthetics
- Patient refusal.
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 |
|---|---|---|
| epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)Anesthesiologist will place epidural with aid of ultrasound and placement with echogenic 17G Tuohy needles (Pajunk TuohySono) | Other | echogenic 17G tuohy needles " Pajunk TuohySono |
| standard epidural placementAnesthesiologist will place epidural within standard practice, with standard needles. | Other | standard epidural needles |
Primary outcome
Real-time ultrasound-guided paramedian epidural access:
Time frame: Day 1
Block success rate will be measured as the rate of cases that will have succesful insertion of the epidural catheter using ultrasound guidance and the case is done completely under epidural anesthesia. The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk TuohySono"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Derived from this study: PubMed 30865772Elsharkawy H, Saasouh W, Babazade R, Soliman LM, Horn JL, Zaky S. Real-time Ultrasound-Guided Lumbar Epidural with Transverse Interlaminar View: Evaluation of an In-Plane Technique. Pain Med. 2019 Sep 1;20(9):1750-1755. doi: 10.1093/pm/pnz026.
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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.
Sherif Zaky, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono) and standard epidural placement in people with Epidural Placement, run by The Cleveland Clinic at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 8 Apr 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-time ultrasound-guided paramedian epidural access: (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01686243, which also lists 1 linked publication.
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 8 Apr 2019.