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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01840995

Collaborator

(none)

Enrollment

Location

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Pain Intracranial Pressure	Procedure: ultrasonographic measurement of optic nerve sheath diameter

Study Design

Study Type:

Observational

Actual Enrollment :

35 participants

Time Perspective:

Prospective

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

ultrasonographic measurement of optic nerve sheath diameter [15 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01840995

Other Study ID Numbers:

4-2013-0078

First Posted:

Apr 26, 2013

Last Update Posted:

Jan 28, 2015

Last Verified:

Jan 1, 2015

Keywords provided by Yonsei University

stellate ganglion block

Study Results

No Results Posted as of Jan 28, 2015