Clinical trial NCT04892290: Sphenopalatine Ganglion Block for Postdural Puncture Headache
Official title: Effectiveness of Sphenopalatine Ganglion Block on Postdural Puncture Headache Treatment: A Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postdural Puncture Headache
Keywords: Sphenopalatine Ganglion Block
Postdural Puncture Headache
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postdural Puncture Headache patients

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Headache in Supine Position
timeFrame: 1st, 3rd, 12th and 24th hours of follow-up
Secondary outcomes:
measure: Headache in Prone Position
timeFrame: 1st, 3rd, 12th and 24th hours of follow-up
measure: Successfully treated patients ratio
timeFrame: 24th hour of follow-up
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Training and Research Hospital
Study officials:
affiliation: Sakarya University
name: Burak Kaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istinye University
name: Serbülent Gökhan Beyaz, Prof MD
role: STUDY_CHAIR
affiliation: Sakarya University
name: Ayça Taş Tuna, As Prof MD
role: STUDY_CHAIR
affiliation: Sakarya University
name: Havva Kocayiğit, MD
role: STUDY_CHAIR
References: