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Completed

NCT Number: NCT05552404

Postdural Puncture Headache Relief With Aminophylline and SPGB

The purpose of the study is to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

faculty of medicine, Ain Shams University

Cairo, 11591, Egypt

About this study

Postdural puncture headache (PDPH) is a severe and debilitating complication after regional anesthesia in the obstetric population; The gold standard treatment for PDPH is epidural blood patch, which is an invasive and risky procedure.

The trans-nasal sphenopalatine ganglion (SPG) block and intravenous aminophylline are promising options for PDPH. So the investigators designed this randomized, double-blind study to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 - 40 years old female.
  • ASA I -II according to the American society of anesthesiologists.
  • Spinal anesthesia with 22G Quincke needle for cesarean section.
  • PDPH was defined according to the international classification of headache disorders, 3rd edition criteria (ICHD-3) as:
  • Headache occurring within 5 days of a lumbar puncture.
  • Orthostatic headache that significantly worsens soon after sitting upright or standing and/or improves after lying horizontally usually accompanied by neck pain, tinnitus, changes in hearing, photophobia, and/or nausea.
  • Exclusion of other causes such as hypertension, preeclampsia, tension headache, migraine, etc.

Exclusion criteria

  • A history of headaches that could interfere with the PDPH diagnosis,
  • A history of central nervous system diseases, including intracranial hemorrhage, seizures, intracranial hypertension, or hydrocephalus
  • A history of cardiovascular diseases, including coronary heart disease, arrhythmias, or hypertension.
  • A history of allergy to or any contraindication for using Aminophylline.
  • Coagulopathy.
  • Nasal septal deviation, polyp, or nasal bleeding.
  • General anesthesia after failed spinal anesthesia.

Treatment and study plan

conservative therapy

Other

bed rest, fluids, abdominal binder, oral paracetamol, and caffeine

Aminophylline

Drug

conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)

trans nasal sphenopalatine ganglion block

Procedure

conservative therapy plus sphenopalatine ganglion block SPGB using hollow cotton swab and lidocaine 2%

Primary outcomes

  1. the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.

    Time frame: at 12 hours

    0 - no pain to 10 - worst pain imaginable

Secondary outcomes

  1. Patient Global impression of change (PGIC) scale

    Time frame: at 24 hours

    Participant encircles number that match degree of change since the begining of care where 0- much better to 10- much worse and 5- no change.

  2. Adverse effects

    Time frame: at 24 hours

    Recording of adverse effects arrhythmias, agitation, and nasal bleeding.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Trans-nasal Sphenopalatine Ganglion Block Versus Intravenous Aminophylline Injection for Treatment of Postdural Puncture Headache After Caesarean Section Under Spinal Anesthesia

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2022
Registry last updated
Jan 11, 2023

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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