NCT01840995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

April 19, 2013

Last Update Submit

January 26, 2015

Conditions

Keywords

stellate ganglion block

Outcome Measures

Primary Outcomes (1)

  • ultrasonographic measurement of optic nerve sheath diameter

    15 minutes

Study Arms (1)

stellate ganglion block

Patients receiving stellate ganglion block at our pain management clinic

Procedure: ultrasonographic measurement of optic nerve sheath diameter

Interventions

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.

stellate ganglion block

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were scheduled to receive stellate ganglion block at our pain management clinic

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related 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.

    PMID: 22258019BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2013

First Posted

April 26, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations