Sphenopalatine Ganglion Block for Postdural Puncture Headache

Overview

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.

Full Title of Study: “Effectiveness of Sphenopalatine Ganglion Block on Postdural Puncture Headache Treatment: A Retrospective Observational Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: April 30, 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • Group C
    • Postdural puncture headache patients treated with Conservative treatment
  • Group SGB
    • Postdural puncture headache patients treated with Sphenopalatine Ganglion Block and conservative treatment

Clinical Trial Outcome Measures

Primary Measures

  • Headache in Supine Position
    • Time Frame: 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 Measures

  • Headache in Prone Position
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sakarya University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Burak Kaya, Anesthesiology and Reanimation Specialist, MD – Sakarya University
  • Overall Official(s)
    • Burak Kaya, MD, Principal Investigator, Sakarya University
    • Serbülent Gökhan Beyaz, Prof MD, Study Chair, Istinye University
    • Ayça Taş Tuna, As Prof MD, Study Chair, Sakarya University
    • Havva Kocayiğit, MD, Study Chair, Sakarya University

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