Is Sphenopalatine Ganglion Block Treatment Effective on Postspinal Headaches (SPG)

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

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.

Study Overview

• Status: Completed
• Conditions: Central Nervous System Diseases; Headache Disorders
• Intervention / Treatment: Procedure: sphenopalatine ganglion block; Drug: conservative treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41900
    • Derince Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sphenopalatine Ganglion Block Group; patients will be performed transnasal sphenopalatine block and conservative treatment ( iv hydration, analgesic agents, caffeine or theophylline)	Procedure: sphenopalatine ganglion block; 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.; Drug: conservative treatment; Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline
Active Comparator: Standard Treatment Group; patients will receive standard supportive treatment ( Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline)	Drug: conservative treatment; Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale Score	VAS score will be asked to the patients. Visual analog scale (VAS) from 0 to 10. 0(= no anxiety), 10(= highest level of anxiety)	24 th hour after intervention

Collaborators and Investigators

• Sponsor: Derince Training and Research Hospital
• Investigators: Study Director: mehmet yilmaz, Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: spinal anesthesia; sphenopalatine ganglion block; postspinal headache
• Additional Relevant MeSH Terms: Brain Diseases; Neoplasms; Pain; Neurologic Manifestations; Cysts; Connective Tissue Diseases; Mucinoses; Nervous System Diseases; Headache; Ganglion Cysts; Headache Disorders; Central Nervous System Diseases
• Other Study ID Numbers: DerinceTRH-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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