Head PainPhase 4NCT01054378
Diaphragmatic Movement Before and After Stellate Ganglion Block : A Ultrasonographic Study
A Phase 4 study testing M-mode ultrasonography in people with Head Pain and Neck Pain, run by Yonsei University at 1 site in South Korea.
Trial summary
The temporary diaphrgmatic dysfunction will occur after stellate ganglion block(SGB) and will be easily detected by M-mode ultrasonography Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Head Pain, Neck Pain, Shoulder Pain
- What is being tested?
- M-mode ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Apr 2010
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I-II patients who have head and neck pain or shoulder pain or sudden sensory neural hearing loss
Who cannot join
- coagulopathy, pulmonary disease, neuropathy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
The temporary diaphrgmatic dysfunction will occur after stellate ganglion block(SGB) and will be easily detected by M-mode ultrasonography
- Conditions
- Head Pain, Neck Pain, Shoulder Pain, Arm Pain, Neural Sensory Hearing Loss
- Being tested
- M-mode ultrasonography
- Medical subject headings
- Headache, Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-mode ultrasonographyProcedure or surgery
Evaluation of diaphragmatic movement using M-mode ultrasonography before and after stellate ganglion block with 1% lidocaine
What is being measured
The primary outcome is the main question the study is designed to answer.
The amplitude of diaphragm movement before and after SGB during quiet breathing, deep breathing and voluntary sniff, inspiratory time and expiratory time, oxygen saturation
Measured: The ultrasonographic evaluation will take place just before and 30 minutes after stellate ganglion block.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Duck Mi Yoon, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054378
- Sponsor's protocol ID
- 4-2009-0614
- Status last verified
- Dec 2010
- First submitted
- 21 Jan 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Movement Before and After Stellate Ganglion Block : A Ultrasonographic Study
- ClinicalTrials.gov ID
- NCT01054378
- Acronym / sponsor ID
- 4-2009-0614
- Conditions
- Head Pain, Neck Pain, Shoulder Pain, Arm Pain, Neural Sensory Hearing Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 22 Jan 2010 (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 temporary diaphrgmatic dysfunction will occur after stellate ganglion block(SGB) and will be easily detected by M-mode ultrasonography
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA class I-II patients who have head and neck pain or shoulder pain or sudden sensory neural hearing loss
Key exclusion criteria (1 listed)
- coagulopathy, pulmonary disease, neuropathy
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 |
|---|---|---|
| M-mode ultrasonographyEvaluation of diaphragmatic movement using M-mode ultrasonography before and after stellate ganglion block with 1% lidocaine | Procedure or surgery | – |
Primary outcome
The amplitude of diaphragm movement before and after SGB during quiet breathing, deep breathing and voluntary sniff, inspiratory time and expiratory time, oxygen saturation
Time frame: The ultrasonographic evaluation will take place just before and 30 minutes after stellate ganglion block.
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 7 Dec 2010.
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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.
Duck Mi Yoon principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing M-mode ultrasonography in people with Head Pain and Neck Pain, 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 1 inclusion and 1 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 7 Dec 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The amplitude of diaphragm movement before and after SGB during quiet breathing, deep breathing and voluntary sniff, inspiratory time and expiratory time, oxygen saturation (time frame: The ultrasonographic evaluation will take place just before and 30 minutes after stellate ganglion block.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2010.