Sphenopalatine Ganglion Block for Postdural Puncture Headache

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

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.

Study Overview

• Status: Completed
• Conditions: Postdural Puncture Headache
• Intervention / Treatment: Other: Conservative Treatment for Postdural Puncture Headache

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Turkey
  • Sakarya, Turkey, 54290
    • Sakarya University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Postdural Puncture Headache patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group C; Postdural puncture headache patients treated with Conservative treatment	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.; Other Names: Sphenopalatine Ganglion Block
Group SGB; Postdural puncture headache patients treated with Sphenopalatine Ganglion Block and conservative treatment	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.; Other Names: Sphenopalatine Ganglion Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sakarya University
• Investigators: Principal Investigator: Burak Kaya, MD, Sakarya University; Study Chair: Serbülent Gökhan Beyaz, Prof MD, Istinye University; Study Chair: Ayça Taş Tuna, As Prof MD, Sakarya University; Study Chair: Havva Kocayiğit, MD, Sakarya University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): May 19, 2020

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (ACTUAL): May 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Sphenopalatine Ganglion Block; Postdural Puncture Headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Pain; Neurologic Manifestations; Cysts; Connective Tissue Diseases; Mucinoses; Headache Disorders; Headache Disorders, Secondary; Wounds and Injuries; Headache; Ganglion Cysts; Post-Dural Puncture Headache
• Other Study ID Numbers: 71522473/050.01.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Database

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No