Sphenopalatine Ganglion Block for Postdural Puncture Headache

NCT ID: NCT04892290

Last Updated: 2021-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-05-19

Brief Summary

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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

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Conditions

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Postdural Puncture Headache

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group C

Postdural puncture headache patients treated with Conservative treatment

Conservative Treatment for Postdural Puncture Headache

Intervention Type 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.

Group SGB

Postdural puncture headache patients treated with Sphenopalatine Ganglion Block and conservative treatment

Conservative Treatment for Postdural Puncture Headache

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Sphenopalatine Ganglion Block

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sakarya University

OTHER

Sponsor Role lead

Responsible Party

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Burak Kaya

Anesthesiology and Reanimation Specialist, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burak Kaya, MD

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

Serbülent Gökhan Beyaz, Prof MD

Role: STUDY_CHAIR

Istinye University

Ayça Taş Tuna, As Prof MD

Role: STUDY_CHAIR

Sakarya University

Havva Kocayiğit, MD

Role: STUDY_CHAIR

Sakarya University

Locations

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Sakarya University Training and Research Hospital

Sakarya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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71522473/050.01.04

Identifier Type: -

Identifier Source: org_study_id

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