Sphenopalatine Ganglion Block for Postdural Puncture Headache

NCT04892290 | Completed

• 1 other identifier: 71522473/050.01.04
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postdural Puncture Headache

Keywords

Sphenopalatine Ganglion Block; Postdural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Headache in Prone Position

  1st, 3rd, 12th and 24th hours of follow-up

• Successfully treated patients ratio

  24th hour of follow-up

Study Arms (2)

Group C

Postdural puncture headache patients treated with Conservative treatment

Other: Conservative Treatment for Postdural Puncture Headache

Group SGB

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

Other: Conservative Treatment for Postdural Puncture Headache

Interventions

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.

Also known as: Sphenopalatine Ganglion Block

Group C; Group SGB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postdural Puncture Headache patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University Training and Research Hospital

Sakarya, 54290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Conservative Treatment; Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Burak Kaya, MD

  Sakarya University

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist, MD

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: December 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: May 19, 2020
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

TU (1)