Sphenopalatine Ganglion Block for Postdural Puncture Headache

Postdural Puncture Headache Clinical Trial

Official title:

Effectiveness of Sphenopalatine Ganglion Block on Postdural Puncture Headache Treatment: A Retrospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892290
• Other study ID #: 71522473/050.01.04
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Ganglion Cysts
• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache
• Wounds and Injuries

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