Comparison of Two Methods of Transnasal Sphenopalatine Ganglion Block

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT04479176

Collaborator

(none)

Enrollment

Location

6.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sphenopalatine Ganglion Block	Procedure: Transnasal Sphenopalatine Ganglion Block

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

Study Type:

Observational

Actual Enrollment :

74 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Comparison of Temperature and Pain Changes Between the Drip and Topical Methods of Administering the Transnasal Sphenopalatine Ganglion Block

Actual Study Start Date :

Mar 10, 2021

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: Transnasal Sphenopalatine Ganglion Block 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.
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.	Procedure: Transnasal Sphenopalatine Ganglion Block 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.

Arm

Intervention/Treatment

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.

Procedure: Transnasal Sphenopalatine Ganglion Block

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.

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.

Procedure: Transnasal Sphenopalatine Ganglion Block

Outcome Measures

Primary Outcome Measures

Facial temperatures [Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block]
Facial temeratures changes after transnasal SPGB
Visual analogue scale(VAS) [Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block]
11 points pain scale score from 0 to 10

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou University Hospital	Suwon	Gyunggi	Korea, Republic of	16499

Sponsors and Collaborators

Ajou University School of Medicine

Investigators

Study Chair: Kim, Ajou University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jong Bum Choi, Assistant Professor, Ajou University School of Medicine

ClinicalTrials.gov Identifier:

NCT04479176

Other Study ID Numbers:

AJIRB-MED-MDB-20-565

First Posted:

Jul 21, 2020

Last Update Posted:

Oct 20, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ganglion Cysts

Synovial Cyst

Study Results

No Results Posted as of Oct 20, 2021