Clinical trial NCT03512977: Is Sphenopalatine Ganglion Block Treatment Effective on Postspinal Headaches
Official title: Effect of the Sphenopalatine Ganglion Block for Post Spinal Headache Treatment: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache Disorders
Central Nervous System Diseases
Keywords: spinal anesthesia
sphenopalatine ganglion block
postspinal headache
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates effect of sphenopalatine ganglion block in post dural puncture headache. Half of participants will receive standard supportive treatment and other half of patients will be performed sphenopalatine ganglion block.

Detailed description: Spinal anesthesia is known subarachnoid block also commonly used regional anesthesia technic. Spinal anesthesia is frequently performed in obstetric patients undergoing cesarian section, which has several advantages including less deep vein thrombosis incidence, low opioid requirement, early mobilization and early lactation also has some complications too. Postdural headache is one of the most known complications of spinal anesthesia.

The etiology of the postspinal headache remains unclear. Severeness of the symptoms and amount of the cerebrospinal fluid leakage have been found positive correlating. The cerebrospinal fluid supports brain with it's mass effect. When a leakage of the fluid occurs, support of the brain decreases and pain sensitive structures of the brain gets more sensitive. In this condition 5 th 9th and 10 th cranial nerves, falks cerebelli, tentorium and blood vessels are affected most. Decreased cerebrospinal fluid volume causes decreased brain volume and compensatory mechanisms lead to cerebral venous dilatation. Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline. Epidural blood patch is the gold standard for the treatment . However epidural blood patch is an invasive technic and has some complications such as dural puncture, infection and neurologic trauma.

Sphenopalatine ganglion is one of the four parasympathetic thin ganglion in skull. Parasympathetic fibers innervates cerebral and meningeal blood vessels which cause vasodilatation and stimulate nociceptor activation on meninges. Consequently headache is related with sensory cortex.

Transnasal SPG block is performed successfully in chronic pain syndromes including migraine, cluster headaches and atypic face pain. Likewise the SPG block is performed in acute treatment of postspinal headache. However gold standard of the treatment is epidural blood patching which is interventional and has many risks. Several studies enrolled limited participants offer SPG block primarily in the literature.

Eligibility criteria: Inclusion Criteria:

* Patients who was diagnosed for postdural puncture headache after cesarian section
* Patients who is fluent speaking and writing in turkish

Exclusion Criteria:

* Refusal to participate in the study
* Patients who was known lidocaine sensitivity
* Patients with severe nasal septum deviation

Primary outcomes:
measure: Visual Analog Scale Score
timeFrame: 24 th hour after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Derince Research and Training Hospital
Study officials:
affiliation: Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi
name: mehmet yilmaz
role: STUDY_DIRECTOR
References: