Transnasal Versus Suprazygomatic SPG Block in Persistant Idiopathic Facial Pain

A Comparison of Transnasal Versus Ultrasound-guided Suprazygomatic Approaches for Sphenopalatine Ganglion Blocks in Persistent Idiopathic Facial Pain

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.

Study Overview

• Status: Completed
• Conditions: Headache; Persistent Idiopathic Facial Pain
• Intervention / Treatment: Drug: Transnasal Sphenopalatine ganglion block; Drug: Ultrasound-guided suprazygomatic sphenopalatine ganglion block

Detailed Description

Patients with chronic head and facial pain are frequently referred to us and some of these patients are persistent idiopathic facial pain patients who do not respond to conservative treatment. Various interventional treatment modalities can be applied to these patients. One of the treatments we frequently apply is sphenopalatine ganglion (SPG) blockage, which has an important place in the pathogenesis of chronic headache. The SPG is the target area for the treatment of cluster headache, migraine, postherpetic neuralgia, trigeminal neuralgia and other atypical facial pain syndromes due to its anatomical localisation and its role in the trigemino-cervical reflex. Although there are various techniques for SPG block, the simplest and most easily applicable is the transnasal approach and the traditional method is to apply a block with a cotton-tipped swab. Various local anaesthetics can be used, the most commonly used local anaesthetic is 2-3 ml of 2% or 10% lidocaine, usually administered through one nostril for 30 minutes. It is also possible to access SPG via the suprazygomatic route, and studies have shown that SPG block applied via the suprazygomatic route provides effective treatment of chronic headaches. In ultrasound-guided SPG block, after visualising the pterygopalatine fossa with USG, 3-4 mL of 2% lidocaine is administered to the area and blockage is achieved.

Our study was designed retrospectively. The primary aim of the study was to compare the efficacy of transnasal and suprazigomatic routes based on Numerical Rating Scale (NRS) pain scores by reviewing the files of patients who underwent sphenopalatine ganglion block for persistent idiopathic facial pain. The pain scores recorded before the procedure and one and four weeks after the procedure will be compared.

In this study, primary aim is to evaluate the efficacy of these two treatment modalities, with retrospectively evaluate the Visual Analogue Scale (VAS) score, HIT-6 (Headache Impact Test-6) score and headache diary data of the patients who have previously undergone these treatments in the pain clinic.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 06100
      • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transnasal sphenopalatine ganglion block group; transnasal administration of lidocaine to the sphenopalatine ganglion	Drug: Transnasal Sphenopalatine ganglion block; 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.
Ultrasound-guided suprazygomatic sphenopalatine ganglion block group; ultrasound-guided suprazygomatic approach	Drug: Ultrasound-guided suprazygomatic sphenopalatine ganglion block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIT-6 (Headache impact test)	HIT-6 is a self-report questionnare designed to evaluate the impact of headache on quality of life. 49 or less: little or no impact, 50-55: some impact, 56-59. substantial impact, 60-78: severe impact	Change from baseline to 1st hour, 1st week and 4th weeks after treatment

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Study Director: Ömer Taylan Akkaya, MD, Diskapi Teaching and Research Hospital; Principal Investigator: Ezgi Can, MD, Diskapi Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 2, 2023

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: headache; ultrasonography; sphenopalatine ganglion block; Persistent Idiopathic Facial Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Headache; Facial Pain; Facies
• Other Study ID Numbers: SPG block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No