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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04892290
Other study ID # 71522473/050.01.04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date May 19, 2020

Study information

Verified date May 2021
Source Sakarya University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date May 19, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Conservative Treatment for Postdural Puncture Headache
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.

Locations

Country Name City State
Turkey Sakarya University Training and Research Hospital Sakarya

Sponsors (1)

Lead Sponsor Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Headache in Supine Position Headache severity changes with Visual Analogue Scale (VAS, 0-10, 0: no pain, 10:worst pain) 1st, 3rd, 12th and 24th hours of follow-up
Secondary Headache in Prone Position Headache severity changes with Visual Analogue Scale (VAS, 0-10, 0: no pain, 10:worst pain) 1st, 3rd, 12th and 24th hours of follow-up
Secondary Successfully treated patients ratio 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. 24th hour of follow-up
See also
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