Transnasal Versus Suprazygomatic SPG Block in Persistant Idiopathic Facial Pain

NCT06496841 | Completed

• 1 other identifier: SPG block
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Headache; Persistent Idiopathic Facial Pain

Keywords

headache; ultrasonography; sphenopalatine ganglion block; Persistent Idiopathic Facial Pain

Outcome Measures

Primary Outcomes (1)

• 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''.

  Change from baseline to 1st hour, 1st week and 4th weeks after treatment

Secondary Outcomes (1)

• HIT-6 (Headache impact test)

  Change from baseline to 1st hour, 1st week and 4th weeks after treatment

Study Arms (2)

Transnasal sphenopalatine ganglion block group

transnasal administration of lidocaine to the sphenopalatine ganglion

Drug: Transnasal Sphenopalatine ganglion block

Ultrasound-guided suprazygomatic sphenopalatine ganglion block group

ultrasound-guided suprazygomatic approach

Drug: Ultrasound-guided suprazygomatic sphenopalatine ganglion block

Interventions

Transnasal Sphenopalatine ganglion block DRUG

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.

Transnasal sphenopalatine ganglion block group

Ultrasound-guided suprazygomatic sphenopalatine ganglion block DRUG

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.

Ultrasound-guided suprazygomatic sphenopalatine ganglion block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female patients who underwent transnasal or ultrasound-guided suprazygomatic sphenopalatin ganglion block for persistant idiopathic facial pain

You may qualify if:

• 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

You may not qualify if:

• Presence of secondary headache (tumor, bleeding, stroke, etc.)
• Cognitive impairment
• Hepatic or renal insufficiency
• Local or systemic infection
• Coagulopathy
• Patient refusal to accept treatment

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ömer Taylan Akkaya, MD

  Diskapi Teaching and Research Hospital

  STUDY DIRECTOR

• Ezgi Can, MD

  Diskapi Teaching and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: October 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 2, 2023
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

TU (1)