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The Optimal Oblique and Axial Angle of Fluoroscope for Superior Hypogastric Plexus Block

This study is currently recruiting participants.
Verified May 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Woo Seog Sim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01604837
First received: May 22, 2012
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition
Chronic Pelvic Pain
Pelvic Malignancy
Superior Hypogastric Plexus Block

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: The Optimal Oblique and Axial Angle of Fluoroscope for Superior Hypogastric Plexus Block

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pelvic Pain
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • the oblique entry angle [ Time Frame: 1 month after abdominopelvic CT scan performed ] [ Designated as safety issue: No ]
    the oblique entry angle of superior hypogastric plexus block at L5-S1 level


Secondary Outcome Measures:
  • the axial entry angle [ Time Frame: 1 month after abdominopelvic CT scan performed ] [ Designated as safety issue: No ]
    the axial entry angle of superior hypogastric plexus block at L4-S1 level


Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604837

Contacts
Contact: Woo Seog Sim, MD, PhD 82-2-3410-0356 wooseog.sim@samsung.com
Contact: Won Ho Kim, MD 82-2-3410-2470 bullet57@naver.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Woo Seog Sim, MD, PhD     82-2-3410-0360     wooseog.sim@samsung.com    
Contact: Won Ho Kim, MD     82-2-3410-2470     bullet57@naver.com    
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Woo Seog Sim, MD, PhD Samsung Medical Center
Principal Investigator: Won Ho Kim, MD Samsung Medical Center
Principal Investigator: Hye Won Song, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Woo Seog Sim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01604837     History of Changes
Other Study ID Numbers: 2012-03-074
Study First Received: May 22, 2012
Last Updated: May 23, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
superior hypogastric plexus block
pelvic malignancy
chronic pelvic pain

Additional relevant MeSH terms:
Neoplasms
Pelvic Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013