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NCT Number: NCT04892290

Sphenopalatine Ganglion Block for Postdural Puncture Headache

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.

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Key information

Conditions

Postdural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Dural Puncture Headache

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sakarya University Training and Research Hospital

Sakarya, 54290, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conservative Treatment for Postdural Puncture Headache

Other

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.

Other names: Sphenopalatine Ganglion Block

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 19, 2021
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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