- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04892290
Sphenopalatine Ganglion Block for Postdural Puncture Headache
Effectiveness of Sphenopalatine Ganglion Block on Postdural Puncture Headache Treatment: A Retrospective Observational Study
Background: Postdural puncture headache (PDPH), which is one of the complications of spinal anesthesia, is a condition that negatively affects the quality of life of patients, causes late mobilization and prolonged hospital stay. Sphenopalatine ganglion block (SGB) has created a minimally invasive, easy, and safe treatment alternative.
Objective: Evaluating the effectiveness of topical SGB on PDPH treatment. Design: Retrospective observational study Setting: Single center tertiary level of care hospital study. The files of PDPH patients between Jan 2018 and Jan 2020 were scanned.
Patients: PDPH patients aged 18-65 are included and any patients with primary/secondary headache history are excluded.
Main outcome measures: Patients were divided into 2 groups. The group that given only conservative treatment was named as Group C, and the group of patients who had additionally been applied SGB was named as Group SGB. Headache severity was measured with Visual Analogue Scale (VAS) at the 1st,3rd, 12th and 24th hours of the treatment, in supine and upright position.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sakarya, Turkey, 54290
- Sakarya University Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18-65 years-old
- not having any headache diagnosis (G44 and subgroup according to the International Classification of Diseases-10 classification),
- developed PDPH according to the International Headaches Classification after the neuraxial procedure
Exclusion Criteria:
- history of primary headaches such as migraine, cluster type, tension type
- secondary headache such as preeclampsia / eclampsia, cerebral venous thrombosis, stroke, ruptured aneurysm, hypertensive encephalopathy, pituitary apoplexy, meningitis and subarachnoid hemorrhage
- any local or systemic infection
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group C
Postdural puncture headache patients treated with Conservative treatment
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The patients in Group C were given continuous bed rest in the supine position, 3000 mL daily hydration, 6 mg kg-1 aminophylline , 2 g day-1 paracetamol and 65 mg day-1 caffeine as conservative treatment.
Topical SGB was applied to patients in Group SGB in addition to conservative treatment.
Other Names:
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Group SGB
Postdural puncture headache patients treated with Sphenopalatine Ganglion Block and conservative treatment
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The patients in Group C were given continuous bed rest in the supine position, 3000 mL daily hydration, 6 mg kg-1 aminophylline , 2 g day-1 paracetamol and 65 mg day-1 caffeine as conservative treatment.
Topical SGB was applied to patients in Group SGB in addition to conservative treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Headache in Supine Position
Time Frame: 1st, 3rd, 12th and 24th hours of follow-up
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Headache severity changes with Visual Analogue Scale (VAS, 0-10, 0: no pain, 10:worst pain)
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1st, 3rd, 12th and 24th hours of follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Headache in Prone Position
Time Frame: 1st, 3rd, 12th and 24th hours of follow-up
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Headache severity changes with Visual Analogue Scale (VAS, 0-10, 0: no pain, 10:worst pain)
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1st, 3rd, 12th and 24th hours of follow-up
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Successfully treated patients ratio
Time Frame: 24th hour of follow-up
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At the 24th hour of their follow-up, all patients with a VAS>3 (Visual Analogue Scale) headache in an upright position are considered as unsuccessful treatment and are directed to the epidural blood patch procedure.
Both groups will be compared with successfully treated patients ratios.
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24th hour of follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Burak Kaya, MD, Sakarya University
- Study Chair: Serbülent Gökhan Beyaz, Prof MD, Istinye University
- Study Chair: Ayça Taş Tuna, As Prof MD, Sakarya University
- Study Chair: Havva Kocayiğit, MD, Sakarya University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 71522473/050.01.04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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