Chronic Pelvic PainNCT01604837
The Optimal Oblique and Axial Angle of Fluoroscope for Superior Hypogastric Plexus Block
An observational study of Chronic Pelvic Pain and Pelvic Malignancy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The recommended entry angle for superior hypogastric plexus block is different among references, and there is a need for suggesting a more accurate entry angle for this procedure. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Pelvic Pain, Pelvic Malignancy, Superior Hypogastric Plexus Block
- How many people
- 268 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Dec 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease
Who may be able to join
- Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease
Who cannot join
- Poor CT image with non-measurable axial or oblique entry angle
Trial locations and contacts
1 site in 1 country.
About this study
The recommended entry angle for superior hypogastric plexus block is different among references, and there is a need for suggesting a more accurate entry angle for this procedure. The investigators are trying to evaluate the entry angle for superior hypogastric plexus block by measuring these angle on the computed tomography image and apply these angle to the real patients.
Read the detailed description
Superior hypogastric plexus block is a kind of sympathetic plexus block which are used to control the pelvic pain caused by malignancy or other chronic condition. Classic posterior approach for this procedure is inserting the block needle at L4 -5 level and proceed the needle 45 degrees medially and 30 degrees caudally to reach the target of anterolateral space of L5 - S1 intervertebral space. Waldman et al. introduced a different angle of 30 degrees medial and caudal with the same approach, while Stevens et al. recommended 15 degrees medial and 20 degrees caudal. As such, the recommended angle for this procedure is different among references, and there is a need for suggesting a more accurate entry angle for this procedure. Therefore, we are trying to evaluate the entry angle for superior hypogastric plexus block by measuring these angle on the computed tomography image and apply these angle to the real patients.
- Keywords
- superior hypogastric plexus block, pelvic malignancy, chronic pelvic pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic malignancy group | those with diagnosis of gynecologic or urologic malignancy | |
| Pelvic chronic disease group | those with chronic pelvic pain with constitutional cause e.g. endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the oblique entry angle
the oblique entry angle of superior hypogastric plexus block at L5-S1 level
Measured: 1 month after abdominopelvic CT scan performed
Secondary outcomes (1)
the axial entry angle
the axial entry angle of superior hypogastric plexus block at L4-S1 level
Measured: 1 month after abdominopelvic CT scan performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational model
- Case-control
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Seog Sim, Samsung Medical Center
- Investigators
- Woo Seog Sim, MD, PhD, Principal investigator, Samsung Medical CenterWon Ho Kim, MD, Principal investigator, Samsung Medical CenterHye Won Song, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604837
- Sponsor's protocol ID
- 2012-03-074
- Status last verified
- Dec 2013
- First submitted
- 22 May 2012
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Oblique and Axial Angle of Fluoroscope for Superior Hypogastric Plexus Block
- ClinicalTrials.gov ID
- NCT01604837
- Acronym / sponsor ID
- 2012-03-074
- Keywords
- superior hypogastric plexus block, pelvic malignancy, chronic pelvic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 May 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 recommended entry angle for superior hypogastric plexus block is different among references, and there is a need for suggesting a more accurate entry angle for this procedure. The investigators are trying to evaluate the entry angle for superior hypogastric plexus block by measuring these angle on the computed tomography image and apply these angle to the real patients.
Detailed description
Superior hypogastric plexus block is a kind of sympathetic plexus block which are used to control the pelvic pain caused by malignancy or other chronic condition. Classic posterior approach for this procedure is inserting the block needle at L4 -5 level and proceed the needle 45 degrees medially and 30 degrees caudally to reach the target of anterolateral space of L5 - S1 intervertebral space. Waldman et al. introduced a different angle of 30 degrees medial and caudal with the same approach, while Stevens et al. recommended 15 degrees medial and 20 degrees caudal. As such, the recommended angle for this procedure is different among references, and there is a need for suggesting a more accurate entry angle for this procedure. Therefore, we are trying to evaluate the entry angle for superior hypogastric plexus block by measuring these angle on the computed tomography image and apply these angle to the real patients.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic malignancy group | – | –those with diagnosis of gynecologic or urologic malignancy |
| Pelvic chronic disease group | – | –those with chronic pelvic pain with constitutional cause e.g. endometriosis |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease
Key inclusion criteria (1 listed)
- Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease
Key exclusion criteria (1 listed)
- Poor CT image with non-measurable axial or oblique entry angle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the oblique entry angle
Time frame: 1 month after abdominopelvic CT scan performed
the oblique entry angle of superior hypogastric plexus block at L5-S1 level
1 secondary outcome
the axial entry angle
Time frame: 1 month after abdominopelvic CT scan performed
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 25 Dec 2013.
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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.
Woo Seog Sim, MD, PhD principal investigator
Samsung Medical Center
Won Ho Kim, MD principal investigator
Samsung Medical Center
Hye Won Song, MD principal investigator
Samsung Medical Center
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 Chronic Pelvic Pain and Pelvic Malignancy, run by Samsung Medical Center 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 1 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 25 Dec 2013. 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?
the oblique entry angle (time frame: 1 month after abdominopelvic CT scan performed). 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 25 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.