- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479176
Comparison of Two Methods of Transnasal Sphenopalatine Ganglion Block
Comparison of Temperature and Pain Changes Between the Drip and Topical Methods of Administering the Transnasal Sphenopalatine Ganglion Block
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gyunggi
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Suwon, Gyunggi, Korea, Republic of, 16499
- Ajou University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
(1) 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.
Exclusion Criteria:
(1) 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
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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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Facial temperatures
Time Frame: Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
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Facial temeratures changes after transnasal SPGB
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Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
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Visual analogue scale(VAS)
Time Frame: Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
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11 points pain scale score from 0 to 10
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Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
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Collaborators and Investigators
Investigators
- Study Chair: Kim, Ajou University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJIRB-MED-MDB-20-565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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