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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2018
CompletedJune 21, 2018
June 1, 2018
7 months
April 12, 2018
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Sphenopalatine Ganglion Block Group
EXPERIMENTALpatients will be performed transnasal sphenopalatine block and conservative treatment ( iv hydration, analgesic agents, caffeine or theophylline)
Standard Treatment Group
ACTIVE COMPARATORpatients will receive standard supportive treatment ( Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline)
Interventions
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 treatments are iv hydration, analgesic agents, caffeine or theophylline
Eligibility Criteria
You may qualify if:
- Patients who was diagnosed for postdural puncture headache after cesarian section
- Patients who is fluent speaking and writing in turkish
You may not qualify if:
- Refusal to participate in the study
- Patients who was known lidocaine sensitivity
- Patients with severe nasal septum deviation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Derince Research and Training Hospital
Kocaeli, 41900, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
mehmet yilmaz
Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
April 12, 2018
First Posted
May 1, 2018
Study Start
December 1, 2017
Primary Completion
June 15, 2018
Study Completion
June 15, 2018
Last Updated
June 21, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share