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Clinical Trials/NCT03512977
NCT03512977
Completed
Not Applicable

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

Derince Training and Research Hospital1 site in 1 country20 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
sphenopalatine ganglion block
Conditions
Headache Disorders
Sponsor
Derince Training and Research Hospital
Enrollment
20
Locations
1
Primary Endpoint
Visual Analog Scale Score
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
June 15, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Derince Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ayse Zeynep Turan

Principle investigator

Derince Training and Research Hospital

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

Arms & Interventions

Sphenopalatine Ganglion Block Group

patients will be performed transnasal sphenopalatine block and conservative treatment ( iv hydration, analgesic agents, caffeine or theophylline)

Intervention: sphenopalatine ganglion block

Sphenopalatine Ganglion Block Group

patients will be performed transnasal sphenopalatine block and conservative treatment ( iv hydration, analgesic agents, caffeine or theophylline)

Intervention: conservative treatment

Standard Treatment Group

patients will receive standard supportive treatment ( Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline)

Intervention: conservative treatment

Outcomes

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)

Study Sites (1)

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