- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01604837
The Optimal Oblique and Axial Angle of Fluoroscope for Superior Hypogastric Plexus Block
December 24, 2013 updated by: Woo Seog Sim, Samsung Medical Center
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
268
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease
Description
Inclusion Criteria:
- Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease
Exclusion Criteria:
- Poor CT image with non-measurable axial or oblique entry angle
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 month after abdominopelvic CT scan performed
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the axial entry angle
Time Frame: 1 month after abdominopelvic CT scan performed
|
the axial entry angle of superior hypogastric plexus block at L4-S1 level
|
1 month after abdominopelvic CT scan performed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Woo Seog Sim, MD, PhD, Samsung Medical Center
- Principal Investigator: Hye Won Song, MD, Samsung Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
May 22, 2012
First Submitted That Met QC Criteria
May 23, 2012
First Posted (Estimate)
May 24, 2012
Study Record Updates
Last Update Posted (Estimate)
December 25, 2013
Last Update Submitted That Met QC Criteria
December 24, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-03-074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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