Sphenopalatine Ganglion Block for Postdural Puncture Headache

Completed

• Conditions: Postdural Puncture Headache
• Interventions: Other: Conservative Treatment for Postdural Puncture Headache

• Registration Number: NCT04892290
• Lead Sponsor: Sakarya University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-19
• Status Verified: 2021-05
• Study First Submitted: 2021-05-14
• Study First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Study First Posted: 2021-05-19
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group C	Conservative Treatment for Postdural Puncture Headache	Postdural puncture headache patients treated with Conservative treatment
Group SGB	Conservative Treatment for Postdural Puncture Headache	Postdural puncture headache patients treated with Sphenopalatine Ganglion Block and conservative treatment

Primary Outcome Measures

Name	Time	Method
Headache in Supine Position	1st, 3rd, 12th and 24th hours of follow-up	Headache severity changes with Visual Analogue Scale (VAS, 0-10, 0: no pain, 10:worst pain)

Secondary Outcome Measures

Name	Time	Method
Headache in Prone Position	1st, 3rd, 12th and 24th hours of follow-up	Headache severity changes with Visual Analogue Scale (VAS, 0-10, 0: no pain, 10:worst pain)
Successfully treated patients ratio	24th hour of follow-up	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.

Trial Locations

Locations (1)

Sakarya University Training and Research Hospital; 🇹🇷 Sakarya, Turkey