HeadacheNCT06496841
Transnasal Versus Suprazygomatic SPG Block in Persistant Idiopathic Facial Pain
An observational study of Headache and Persistent Idiopathic Facial Pain, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The International Headache Society defines persistent idiopathic facial pain (PIFP) as persistent facial pain that does not have the characteristics of cranial neuralgia, is blunt, persistent, persistent, bothersome and not attributable to another disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Persistent Idiopathic Facial Pain
- What is being tested?
- Transnasal Sphenopalatine ganglion block and Ultrasound-guided suprazygomatic sphenopalatine ganglion block
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 2 Apr 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients who underwent transnasal or ultrasound-guided suprazygomatic sphenopalatin ganglion block for persistant idiopathic facial pain
Who may be able to join
- Diagnosis of persistent idiopathic facial pain according to ICHD-3 beta criteria
- Moderate to severe pain (pain of 6 or more on a numeric pain scale of 0-10)
- Persistence of pain for more than 6 months
- Pain unresponsive to conservative methods
Who cannot join
- Presence of secondary headache (tumor, bleeding, stroke, etc.)
- Cognitive impairment
- Hepatic or renal insufficiency
- Local or systemic infection
- Coagulopathy
- Patient refusal to accept treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06100
About this study
Official title: A Comparison of Transnasal Versus Ultrasound-guided Suprazygomatic Approaches for Sphenopalatine Ganglion Blocks in Persistent Idiopathic Facial Pain
The International Headache Society defines persistent idiopathic facial pain (PIFP) as persistent facial pain that does not have the characteristics of cranial neuralgia, is blunt, persistent, persistent, bothersome and not attributable to another disorder. The management of persistent idiopathic facial pain (PIFP) is complex. The sphenopalatine ganglion (SPG) has been the target of interventional treatment of many facial pain syndromes. The sphenopalatine ganglion can be accessed by transnasal access and ultrasound or scopy guidance. In this study, datas compared the efficacy of transnasal approach and ultrasound-guided suprazigomatic approach in sphenopalatine ganglion block in patients with persistent idiopathic facial pain.
Read the detailed description
Patients with chronic head and facial pain are frequently referred to us and some of these patients are persistent idiopathic facial pain patients who do not respond to conservative treatment. Various interventional treatment modalities can be applied to these patients. One of the treatments we frequently apply is sphenopalatine ganglion (SPG) blockage, which has an important place in the pathogenesis of chronic headache. The SPG is the target area for the treatment of cluster headache, migraine, postherpetic neuralgia, trigeminal neuralgia and other atypical facial pain syndromes due to its anatomical localisation and its role in the trigemino-cervical reflex. Although there are various techniques for SPG block, the simplest and most easily applicable is the transnasal approach and the traditional method is to apply a block with a cotton-tipped swab. Various local anaesthetics can be used, the most commonly used local anaesthetic is 2-3 ml of 2% or 10% lidocaine, usually administered through one nostril for 30 minutes. It is also possible to access SPG via the suprazygomatic route, and studies have shown that SPG block applied via the suprazygomatic route provides effective treatment of chronic headaches. In ultrasound-guided SPG block, after visualising the pterygopalatine fossa with USG, 3-4 mL of 2% lidocaine is administered to the area and blockage is achieved.
Our study was designed retrospectively. The primary aim of the study was to compare the efficacy of transnasal and suprazigomatic routes based on Numerical Rating Scale (NRS) pain scores by reviewing the files of patients who underwent sphenopalatine ganglion block for persistent idiopathic facial pain. The pain scores recorded before the procedure and one and four weeks after the procedure will be compared.
In this study, primary aim is to evaluate the efficacy of these two treatment modalities, with retrospectively evaluate the Visual Analogue Scale (VAS) score, HIT-6 (Headache Impact Test-6) score and headache diary data of the patients who have previously undergone these treatments in the pain clinic.
- Conditions
- Headache, Persistent Idiopathic Facial Pain
- Being tested
- Transnasal Sphenopalatine ganglion block, Ultrasound-guided suprazygomatic sphenopalatine ganglion block
- Keywords
- headache, ultrasonography, sphenopalatine ganglion block, Persistent Idiopathic Facial Pain
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal Sphenopalatine ganglion blockDrug
The transnasal approach to the sphenopalatine ganglion block allows for non-invasive access to the sphenopalatine ganglion, which is located deep in the nasopharynx in a recess posterior to the middle turbinate. A long cotton swab is inserted posterior to the nasopharynx until it is properly seated, and 2 mL of 2% lidocaine is injected through the outer end of the swab and left for 30 minutes. Patients are monitored for any potential complications or adverse effects throughout the procedure and for a period of time afterwards.
Ultrasound-guided suprazygomatic sphenopalatine ganglion blockDrug
The ultrasound transducer is placed in the infrazygomatic area, above the maxilla, at approximately a 45 cephalad angle. With this transducer position, the ptrigopalatine fossa, bounded anteriorly by the maxilla and posteriorly by the pterygoid process, is visualized. A 25 gauge spinal needle is inserted 1 to 1.5 cm above the zygomatic arch and posterior to the posterior orbital rim and advanced through an out-of-plane approach to reach the pterigolapalatine fossa. After the aspiration test, 3 mL of 2% lidocaine is injected and the spread of the drug is monitored by ultrasound. Patients are monitored for possible side effects and complications.
| Study group | Role | What they receive |
|---|---|---|
| Transnasal sphenopalatine ganglion block group | transnasal administration of lidocaine to the sphenopalatine ganglion Receives: Drug: Transnasal Sphenopalatine ganglion block | |
| Ultrasound-guided suprazygomatic sphenopalatine ganglion block group | ultrasound-guided suprazygomatic approach Receives: Drug: Ultrasound-guided suprazygomatic sphenopalatine ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
NRS is a pain screening Scale, in time using a 0-10 Scale, with zero meaning ''no pain'' and 10 meaning ''the worst pain imaginable''.
Measured: Change from baseline to 1st hour, 1st week and 4th weeks after treatment
Secondary outcomes (1)
HIT-6 (Headache impact test)
HIT-6 is a self-report questionnare designed to evaluate the impact of headache on quality of life. 49 or less: little or no impact, 50-55: some impact, 56-59. substantial impact, 60-78: severe impact
Measured: Change from baseline to 1st hour, 1st week and 4th weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Oct 2022
- Primary completion1 Apr 2023
- Study completion2 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Ömer Taylan Akkaya, MD, Study director, Diskapi Teaching and Research HospitalEzgi Can, MD, Principal investigator, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496841
- Sponsor's protocol ID
- SPG block
- Status last verified
- Aug 2024
- First submitted
- 4 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Transnasal Versus Ultrasound-guided Suprazygomatic Approaches for Sphenopalatine Ganglion Blocks in Persistent Idiopathic Facial Pain
- ClinicalTrials.gov ID
- NCT06496841
- Acronym / sponsor ID
- SPG block
- Conditions
- Headache, Persistent Idiopathic Facial Pain
- Keywords
- headache, ultrasonography, sphenopalatine ganglion block, Persistent Idiopathic Facial Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 2 Apr 2023 (actual)
- First posted
- 11 Jul 2024 (actual)
- 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 International Headache Society defines persistent idiopathic facial pain (PIFP) as persistent facial pain that does not have the characteristics of cranial neuralgia, is blunt, persistent, persistent, bothersome and not attributable to another disorder. The management of persistent idiopathic facial pain (PIFP) is complex. The sphenopalatine ganglion (SPG) has been the target of interventional treatment of many facial pain syndromes. The sphenopalatine ganglion can be accessed by transnasal access and ultrasound or scopy guidance. In this study, datas compared the efficacy of transnasal approach and ultrasound-guided suprazigomatic approach in sphenopalatine ganglion block in patients with persistent idiopathic facial pain.
Detailed description
Patients with chronic head and facial pain are frequently referred to us and some of these patients are persistent idiopathic facial pain patients who do not respond to conservative treatment. Various interventional treatment modalities can be applied to these patients. One of the treatments we frequently apply is sphenopalatine ganglion (SPG) blockage, which has an important place in the pathogenesis of chronic headache. The SPG is the target area for the treatment of cluster headache, migraine, postherpetic neuralgia, trigeminal neuralgia and other atypical facial pain syndromes due to its anatomical localisation and its role in the trigemino-cervical reflex. Although there are various techniques for SPG block, the simplest and most easily applicable is the transnasal approach and the traditional method is to apply a block with a cotton-tipped swab. Various local anaesthetics can be used, the most commonly used local anaesthetic is 2-3 ml of 2% or 10% lidocaine, usually administered through one nostril for 30 minutes. It is also possible to access SPG via the suprazygomatic route, and studies have shown that SPG block applied via the suprazygomatic route provides effective treatment of chronic headaches. In ultrasound-guided SPG block, after visualising the pterygopalatine fossa with USG, 3-4 mL of 2% lidocaine is administered to the area and blockage is achieved.
Our study was designed retrospectively. The primary aim of the study was to compare the efficacy of transnasal and suprazigomatic routes based on Numerical Rating Scale (NRS) pain scores by reviewing the files of patients who underwent sphenopalatine ganglion block for persistent idiopathic facial pain. The pain scores recorded before the procedure and one and four weeks after the procedure will be compared.
In this study, primary aim is to evaluate the efficacy of these two treatment modalities, with retrospectively evaluate the Visual Analogue Scale (VAS) score, HIT-6 (Headache Impact Test-6) score and headache diary data of the patients who have previously undergone these treatments in the pain clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transnasal sphenopalatine ganglion block group | – | Drug: Transnasal Sphenopalatine ganglion blocktransnasal administration of lidocaine to the sphenopalatine ganglion |
| Ultrasound-guided suprazygomatic sphenopalatine ganglion block group | – | Drug: Ultrasound-guided suprazygomatic sphenopalatine ganglion blockultrasound-guided suprazygomatic approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients who underwent transnasal or ultrasound-guided suprazygomatic sphenopalatin ganglion block for persistant idiopathic facial pain
Key inclusion criteria (4 listed)
- Diagnosis of persistent idiopathic facial pain according to ICHD-3 beta criteria
- Moderate to severe pain (pain of 6 or more on a numeric pain scale of 0-10)
- Persistence of pain for more than 6 months
- Pain unresponsive to conservative methods
Key exclusion criteria (6 listed)
- Presence of secondary headache (tumor, bleeding, stroke, etc.)
- Cognitive impairment
- Hepatic or renal insufficiency
- Local or systemic infection
- Coagulopathy
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 |
|---|---|---|
| Transnasal Sphenopalatine ganglion blockThe transnasal approach to the sphenopalatine ganglion block allows for non-invasive access to the sphenopalatine ganglion, which is located deep in the nasopharynx in a recess posterior to the middle turbinate. A long cotton swab is inserted posterior to the nasopharynx until it is properly seated, and 2 mL of 2% lidocaine is injected through the outer end of the swab and left for 30 minutes. Patients are monitored for any potential complications or adverse effects throughout the procedure and for a period of time afterwards. | Drug | Transnasal sphenopalatine ganglion block group |
| Ultrasound-guided suprazygomatic sphenopalatine ganglion blockThe ultrasound transducer is placed in the infrazygomatic area, above the maxilla, at approximately a 45 cephalad angle. With this transducer position, the ptrigopalatine fossa, bounded anteriorly by the maxilla and posteriorly by the pterygoid process, is visualized. A 25 gauge spinal needle is inserted 1 to 1.5 cm above the zygomatic arch and posterior to the posterior orbital rim and advanced through an out-of-plane approach to reach the pterigolapalatine fossa. After the aspiration test, 3 mL of 2% lidocaine is injected and the spread of the drug is monitored by ultrasound. Patients are monitored for possible side effects and complications. | Drug | Ultrasound-guided suprazygomatic sphenopalatine ganglion block group |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: Change from baseline to 1st hour, 1st week and 4th weeks after treatment
NRS is a pain screening Scale, in time using a 0-10 Scale, with zero meaning ''no pain'' and 10 meaning ''the worst pain imaginable''.
1 secondary outcome
HIT-6 (Headache impact test)
Time frame: Change from baseline to 1st hour, 1st week and 4th weeks after treatment
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 5 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ömer Taylan Akkaya, MD study director
Diskapi Teaching and Research Hospital
Ezgi Can, MD principal investigator
Diskapi Teaching and Research Hospital
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 Headache and Persistent Idiopathic Facial Pain, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 5 Aug 2024. 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 Turkey (Türkiye). 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?
Numerical Rating Scale (NRS) (time frame: Change from baseline to 1st hour, 1st week and 4th weeks after treatment). 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 5 Aug 2024.