PainNCT01840995
The Effect of Stellate Ganglion Block on Intracranial Pressure Predicted by Ultrasonographic Assessment of Optic Nerve Sheath Diameter
An observational study of Pain and Intracranial Pressure, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pain, Intracranial Pressure
- What is being tested?
- ultrasonographic measurement of optic nerve sheath diameter
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were scheduled to receive stellate ganglion block at our pain management clinic
Who may be able to join
- Adult patients (20-70 years of age)
- who were scheduled to receive stellate ganglion block at our pain management clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pain, Intracranial Pressure
- Being tested
- ultrasonographic measurement of optic nerve sheath diameter
- Keywords
- stellate ganglion block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic measurement of optic nerve sheath diameterProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| stellate ganglion block | Patients receiving stellate ganglion block at our pain management clinic Receives: Procedure: ultrasonographic measurement of optic nerve sheath diameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasonographic measurement of optic nerve sheath diameter
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840995
- Sponsor's protocol ID
- 4-2013-0078
- Status last verified
- Jan 2015
- First submitted
- 19 Apr 2013
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22258019
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stellate Ganglion Block on Intracranial Pressure Predicted by Ultrasonographic Assessment of Optic Nerve Sheath Diameter
- ClinicalTrials.gov ID
- NCT01840995
- Acronym / sponsor ID
- 4-2013-0078
- Conditions
- Pain, Intracranial Pressure
- Keywords
- stellate ganglion block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stellate ganglion block | – | Procedure: ultrasonographic measurement of optic nerve sheath diameterPatients receiving stellate ganglion block at our pain management clinic |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were scheduled to receive stellate ganglion block at our pain management clinic
Key inclusion criteria (2 listed)
- Adult patients (20-70 years of age)
- who were scheduled to receive stellate ganglion block at our pain management clinic
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonographic measurement of optic nerve sheath diameterA 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. | Procedure or surgery | stellate ganglion block |
Primary outcome
ultrasonographic measurement of optic nerve sheath diameter
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
- Background: PubMed 22258019Dubost 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.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Intracranial Pressure, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasonographic measurement of optic nerve sheath diameter (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01840995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015; AzTrials last refreshed its copy on 8 Nov 2026.