Sphenopalatine Ganglion BlockNCT04479176
Comparison of Two Methods of Transnasal Sphenopalatine Ganglion Block
An observational study of Sphenopalatine Ganglion Block, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The transnasal sphenopalatine ganglion block(SPGB) is administered to patients with facial or head and neck pain. In the transnasal approach, the drip and topical methods are frequently used. We compared facial temperatures and VAS after transnasal SPGB. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sphenopalatine Ganglion Block
- What is being tested?
- Transnasal Sphenopalatine Ganglion Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2021to 1 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who visited pain clinic of Ajou university hospital, and a total of 74 patients who be performed transnasal sphenopalatine ganglion block
Who may be able to join
- age over 20 years ; (2) head and neck pain; (3) pain score > 4 on the VAS in the head and neck; and (4) having undergone a transnasal SPGB and having had facial temperatures measured.
Who cannot join
- patients with a history of head and neck surgery, (2) treatment with a vasodilator or vasoconstrictor, (3) contraindication to treatment using a transnasal approach, (4) clinically significant systemic disease or any reduced organ failure, and (5) missing data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Temperature and Pain Changes Between the Drip and Topical Methods of Administering the Transnasal Sphenopalatine Ganglion Block
The transnasal sphenopalatine ganglion block(SPGB) is administered to patients with facial or head and neck pain. In the transnasal approach, the drip and topical methods are frequently used. We compared facial temperatures and VAS after transnasal SPGB.
Read the detailed description
The objective of this study was to compare facial temperatures and visual analogue scale (VAS) between drip method and topical method of transnasal sphenopalatine ganglion block (SPGB).
The transnasal SPGB is administered to patients with facial or head and neck pain. In the transnasal approach, the drip and topical methods are frequently used. We compared facial temperatures and VAS after transnasal SPGB.
Medical records of 74 patients who visited the pain clinic and underwent transnasal SPGB were retrospectively reviewed. A total of 156 transnasal SPGB were performed. The patients were divided into the drip-method and topical-method groups. Facial temperatures were measured in six areas of the right and left forehead, maxilla, and mandible before and 30 min after completion of the transnasal SPGB. Temperatures were compared before and 30 min after SPGB in each group and between the two groups. VAS scores were compared at same times of SPGB in each group and between the two groups.
- Conditions
- Sphenopalatine Ganglion Block
- Being tested
- Transnasal Sphenopalatine Ganglion Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal Sphenopalatine Ganglion BlockProcedure or surgery
In transnasal approach, several authors described the traditional technique using sterile 10cm cotton tipped applicators that are dipped in the chosen anesthetic and then advanced along the superior border of the middle turbinate, until it reaches the posterior wall of the nasopharynx. Some other techniques had described dripping one or two ml of the anesthetics into the nostril.
| Study group | Role | What they receive |
|---|---|---|
| Drip-method group | Transnasal SPGB was performed by a single pain clinician. After the patient was placed in a supine and neck-extended position, 2 mL of 2% mepivacaine was placed in a syringe connected to a 16-gauge Angiocath sheath. The sheath of the Angiocath was inserted through the nostril, and 2% mepivacaine was dripped into the nostrils with the patient in a supine position. The mepivacaine drip on the nasal pharynx was maintained for 10 min. A drip of 2% mepivacaine was delivered to the nostril, where the pain was dominant. In cases of bilateral pain, mepivacaine drip was administered to both nostrils. Receives: Procedure: Transnasal Sphenopalatine Ganglion Block | |
| Topical-method group | Transnasal SPGB was performed by a single pain clinician. The posture was the same as that in the drip method. A cotton tip applicator soaked with 2% mepivacaine was inserted vertically into the nostril. After the cotton tip applicator made contact with the posterior wall of the middle turbinate, the cotton tip applicator was fixed for 10 min. A cotton tip applicator was inserted into the nostril, where the pain was dominant. In cases of bilateral pain, two applicators were inserted into both nostrils. Receives: Procedure: Transnasal Sphenopalatine Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial temperatures
Facial temeratures changes after transnasal SPGB
Measured: Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
Visual analogue scale(VAS)
11 points pain scale score from 0 to 10
Measured: Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start10 Mar 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sphenopalatine Ganglion BlockStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Bum Choi, Ajou University School of Medicine
- Investigators
- Kim, Study chair, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479176
- Sponsor's protocol ID
- AJIRB-MED-MDB-20-565
- Status last verified
- Oct 2021
- First submitted
- 15 Jul 2020
- Last updated
- 20 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Temperature and Pain Changes Between the Drip and Topical Methods of Administering the Transnasal Sphenopalatine Ganglion Block
- ClinicalTrials.gov ID
- NCT04479176
- Acronym / sponsor ID
- AJIRB-MED-MDB-20-565
- Conditions
- Sphenopalatine Ganglion Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 21 Jul 2020 (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 transnasal sphenopalatine ganglion block(SPGB) is administered to patients with facial or head and neck pain. In the transnasal approach, the drip and topical methods are frequently used. We compared facial temperatures and VAS after transnasal SPGB.
Detailed description
The objective of this study was to compare facial temperatures and visual analogue scale (VAS) between drip method and topical method of transnasal sphenopalatine ganglion block (SPGB).
The transnasal SPGB is administered to patients with facial or head and neck pain. In the transnasal approach, the drip and topical methods are frequently used. We compared facial temperatures and VAS after transnasal SPGB.
Medical records of 74 patients who visited the pain clinic and underwent transnasal SPGB were retrospectively reviewed. A total of 156 transnasal SPGB were performed. The patients were divided into the drip-method and topical-method groups. Facial temperatures were measured in six areas of the right and left forehead, maxilla, and mandible before and 30 min after completion of the transnasal SPGB. Temperatures were compared before and 30 min after SPGB in each group and between the two groups. VAS scores were compared at same times of SPGB in each group and between the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drip-method group | – | Procedure: Transnasal Sphenopalatine Ganglion BlockTransnasal SPGB was performed by a single pain clinician. After the patient was placed in a supine and neck-extended position, 2 mL of 2% mepivacaine was placed in a syringe connected to a 16-gauge Angiocath sheath. The sheath of the Angiocath was inserted through the nostril, and 2% mepivacaine was dripped into the nostrils with the patient in a supine position. The mepivacaine drip on the nasal pharynx was maintained for 10 min. A drip of 2% mepivacaine was delivered to the nostril, where the pain was dominant. In cases of bilateral pain, mepivacaine drip was administered to both nostrils. |
| Topical-method group | – | Procedure: Transnasal Sphenopalatine Ganglion BlockTransnasal SPGB was performed by a single pain clinician. The posture was the same as that in the drip method. A cotton tip applicator soaked with 2% mepivacaine was inserted vertically into the nostril. After the cotton tip applicator made contact with the posterior wall of the middle turbinate, the cotton tip applicator was fixed for 10 min. A cotton tip applicator was inserted into the nostril, where the pain was dominant. In cases of bilateral pain, two applicators were inserted into both nostrils. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who visited pain clinic of Ajou university hospital, and a total of 74 patients who be performed transnasal sphenopalatine ganglion block
Key inclusion criteria (1 listed)
- age over 20 years ; (2) head and neck pain; (3) pain score > 4 on the VAS in the head and neck; and (4) having undergone a transnasal SPGB and having had facial temperatures measured.
Key exclusion criteria (1 listed)
- patients with a history of head and neck surgery, (2) treatment with a vasodilator or vasoconstrictor, (3) contraindication to treatment using a transnasal approach, (4) clinically significant systemic disease or any reduced organ failure, and (5) missing data.
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 BlockIn transnasal approach, several authors described the traditional technique using sterile 10cm cotton tipped applicators that are dipped in the chosen anesthetic and then advanced along the superior border of the middle turbinate, until it reaches the posterior wall of the nasopharynx. Some other techniques had described dripping one or two ml of the anesthetics into the nostril. | Procedure or surgery | Drip-method group, Topical-method group |
Primary outcome
Facial temperatures
Time frame: Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
Facial temeratures changes after transnasal SPGB
Visual analogue scale(VAS)
Time frame: Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
11 points pain scale score from 0 to 10
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 20 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Kim study chair
Ajou University School of Medicine
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 Sphenopalatine Ganglion Block, run by Ajou University School of Medicine 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 20 Oct 2021. 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?
Facial temperatures (time frame: Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block). The study lists 2 primary outcomes in all. 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 20 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.