Is Sphenopalatine Ganglion Block Treatment Effective on Postspinal Headaches

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.

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Key information

Conditions

Headache Disorders Brain Diseases Central Nervous System Diseases Headache Disorders, Secondary Nervous System Diseases Post-Dural Puncture Headache

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Derince Research and Training Hospital

Kocaeli, 41900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sphenopalatine Ganglion Block

Procedure

the intervention will be performed on sitting position. Lidocaine 2% viscous (0.5ml) will be apply on cotton swab sticks and one will be gently inserted into nostril, along the floor of the nose. Stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab stick will be left undisturbed for 20 minutes.

Conservative treatment

Drug

Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline

Primary outcomes

Visual Analog Scale Score

Time frame: 24 th hour after intervention

VAS score will be asked to the patients. Visual analog scale (VAS) from 0 to 10. 0(= no anxiety), 10(= highest level of anxiety)

Sponsors and collaborators

Lead sponsor

Derince Training and Research Hospital

Other

Registry information

Official study title

Effect of the Sphenopalatine Ganglion Block for Post Spinal Headache Treatment: A Prospective Randomized Controlled Study

Acronym: SPG

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: May 1, 2018
Registry last updated: Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed