Patient Who Needs Epidural BlockNCT01136018
A Prospective Evaluation of Iodinated Contrast Flow Patterns in Caudal Epidurography With Intentional Lateral Caudal Approach
An observational study of Patient Who Needs Epidural Block, run by Yonsei University at 1 site in South Korea.
Trial summary
Caudal epidural block is useful not only for regional anesthesia of low abdominal, perineal area or lower extremities but for relieving acute or chronic pain of low back and lower extremities. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patient Who Needs Epidural Block
- What is being tested?
- insertion needle via intentionally lateral direction.
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Apr 2011
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 24
Who may be able to join
- patients with unilateral radiculopathy
Who cannot join
- patients with sepsis
- chronic infection
- coagulopathy
- local infection near the sacral hiatus
- the allergy of the contrast
- history of spine surgery, scoliosis and kyphosis
Trial locations and contacts
1 site in 1 country.
About this study
Caudal epidural block is useful not only for regional anesthesia of low abdominal, perineal area or lower extremities but for relieving acute or chronic pain of low back and lower extremities. Recently, there were some reports that there was a difference of the contrast flow pattern during lumbar epidural block according to a location of needle tip in the lumbar epidural space. Therefore, the investigators hypothesize that there is a difference of contrast flow pattern in caudal epidurography when a needle is inserted with intentionally lateral direction.
- Conditions
- Patient Who Needs Epidural Block
- Being tested
- insertion needle via intentionally lateral direction.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insertion needle via intentionally lateral direction.Procedure or surgery
evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach
| Study group | Role | What they receive |
|---|---|---|
| intentional lateral caudal approach | Not described Receives: Procedure: insertion needle via intentionally lateral direction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A prospective evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach
Caudal epidural block is useful not only for regional anesthesia of low abdominal, perineal area or lower extremities but for relieving acute or chronic pain of low back and lower extremities. Recently, there were some reports that there was a difference of the contrast flow pattern during lumbar epidural block according to a location of needle tip in the lumbar epidural space. Therefore, the investigator hypothesizes that there is a difference of contrast flow pattern in caudal epidurography when a needle is inserted with intentionally lateral direction.
Measured: during 10 seconds after obtaining the caudal epidurogram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Who Needs Epidural BlockStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136018
- Sponsor's protocol ID
- 4-2010-0016
- Status last verified
- Apr 2011
- First submitted
- 26 May 2010
- Last updated
- 19 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Iodinated Contrast Flow Patterns in Caudal Epidurography With Intentional Lateral Caudal Approach
- ClinicalTrials.gov ID
- NCT01136018
- Acronym / sponsor ID
- 4-2010-0016
- Conditions
- Patient Who Needs Epidural Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 Jun 2010 (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.
Caudal epidural block is useful not only for regional anesthesia of low abdominal, perineal area or lower extremities but for relieving acute or chronic pain of low back and lower extremities. Recently, there were some reports that there was a difference of the contrast flow pattern during lumbar epidural block according to a location of needle tip in the lumbar epidural space. Therefore, the investigators hypothesize that there is a difference of contrast flow pattern in caudal epidurography when a needle is inserted with intentionally lateral direction.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intentional lateral caudal approach | – | Procedure: insertion needle via intentionally lateral direction. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 24
Key inclusion criteria (1 listed)
- patients with unilateral radiculopathy
Key exclusion criteria (6 listed)
- patients with sepsis
- chronic infection
- coagulopathy
- local infection near the sacral hiatus
- the allergy of the contrast
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 |
|---|---|---|
| insertion needle via intentionally lateral direction.evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach | Procedure or surgery | intentional lateral caudal approach |
Primary outcome
A prospective evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach
Time frame: during 10 seconds after obtaining the caudal epidurogram
Caudal epidural block is useful not only for regional anesthesia of low abdominal, perineal area or lower extremities but for relieving acute or chronic pain of low back and lower extremities. Recently, there were some reports that there was a difference of the contrast flow pattern during lumbar epidural block according to a location of needle tip in the lumbar epidural space. Therefore, the investigator hypothesizes that there is a difference of contrast flow pattern in caudal epidurography when a needle is inserted with intentionally lateral direction.
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 19 Apr 2011.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Who Needs Epidural Block, run by Yonsei University at 1 site in South Korea.
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 6 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 19 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 South Korea. 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?
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?
A prospective evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach (time frame: during 10 seconds after obtaining the caudal epidurogram). 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 19 Apr 2011.