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The Effect of Stellate Ganglion Block on Intracranial Pressure Predicted by Ultrasonographic Assessment of Optic Nerve Sheath Diameter

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ClinicalTrials.gov Identifier: NCT01840995
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
The stellate ganglion block increase cerebral blood flow, as the consequence of that, it has the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by ultrasonographic measurement of ONSD after the stellate ganglion block.

Condition or disease Intervention/treatment
Pain Intracranial Pressure Procedure: ultrasonographic measurement of optic nerve sheath diameter

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Study Type : Observational
Actual Enrollment : 35 participants
Time Perspective: Prospective
Study Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Group/Cohort Intervention/treatment
stellate ganglion block
Patients receiving stellate ganglion block at our pain management clinic
Procedure: ultrasonographic measurement of optic nerve sheath diameter
A thick layer of gel is applied on the upper closed eyelid. The linear 13- to 6-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Two measurements are taken for each optic nerve: one in the transverse plane, with the probe being horizontal, and one in the sagittal plane, with the probe being vertical. The final ONSD is the mean of these measurements.




Primary Outcome Measures :
  1. ultrasonographic measurement of optic nerve sheath diameter [ Time Frame: 15 minutes ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who were scheduled to receive stellate ganglion block at our pain management clinic
Criteria

Inclusion Criteria:

  • Adult patients (20-70 years of age)
  • who were scheduled to receive stellate ganglion block at our pain management clinic

Exclusion Criteria:

  • Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery
  • Patients with coagulation disorder
  • Patients with severe obesity
  • Patients with severe cardiovascular or pulmonary disease
  • Patients with cognitive deficits or psychiatric illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840995


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01840995     History of Changes
Other Study ID Numbers: 4-2013-0078
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015
Keywords provided by Yonsei University:
stellate ganglion block