NCT04479176

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

July 15, 2020

Last Update Submit

October 12, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Facial temperatures

    Facial temeratures changes after transnasal SPGB

    Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block

  • Visual analogue scale(VAS)

    11 points pain scale score from 0 to 10

    Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block

Study Arms (2)

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

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

Interventions

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.

Drip-method groupTopical-method group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, Gyunggi, 16499, South Korea

Location

Study Officials

  • Kim

    Ajou University School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 21, 2020

Study Start

March 10, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

October 20, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations