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

Primary Purpose

Headache Disorders, Central Nervous System Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
sphenopalatine ganglion block
conservative treatment
Sponsored by
Derince Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache Disorders focused on measuring spinal anesthesia, sphenopalatine ganglion block, postspinal headache

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Derince Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sphenopalatine Ganglion Block Group

Standard Treatment Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
April 12, 2018
Last Updated
June 20, 2018
Sponsor
Derince Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03512977
Brief Title
Is Sphenopalatine Ganglion Block Treatment Effective on Postspinal Headaches
Acronym
SPG
Official Title
Effect of the Sphenopalatine Ganglion Block for Post Spinal Headache Treatment: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derince Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders, Central Nervous System Diseases
Keywords
spinal anesthesia, sphenopalatine ganglion block, postspinal headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sphenopalatine Ganglion Block Group
Arm Type
Experimental
Arm Description
patients will be performed transnasal sphenopalatine block and conservative treatment ( iv hydration, analgesic agents, caffeine or theophylline)
Arm Title
Standard Treatment Group
Arm Type
Active Comparator
Arm Description
patients will receive standard supportive treatment ( Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline)
Intervention Type
Procedure
Intervention Name(s)
sphenopalatine ganglion block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
conservative treatment
Intervention Description
Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline
Primary Outcome Measure Information:
Title
Visual Analog Scale Score
Description
VAS score will be asked to the patients. Visual analog scale (VAS) from 0 to 10. 0(= no anxiety), 10(= highest level of anxiety)
Time Frame
24 th hour after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mehmet yilmaz
Organizational Affiliation
Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi
Official's Role
Study Director
Facility Information:
Facility Name
Derince Research and Training Hospital
City
Kocaeli
ZIP/Postal Code
41900
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Is Sphenopalatine Ganglion Block Treatment Effective on Postspinal Headaches

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