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NCT01840995 Clinical Trial

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

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01840995
Other study ID # 4-2013-0078
Secondary ID
Status Completed
Phase N/A
First received April 19, 2013
Last updated January 26, 2015
Start date April 2013
Est. completion date December 2013

Study information
Verified date January 2015
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary ultrasonographic measurement of optic nerve sheath diameter 15 minutes No
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