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NCT05552404 | Completed | Anesthesia


Postdural Puncture Headache Relief With Aminophylline and SPGB
Sponsor:

Ain Shams University

Information provided by (Responsible Party):

Tamer Samir Abdelsalam

Brief Summary:

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

Condition or disease

Anesthesia

Intervention/treatment

conservative therapy

Aminophylline

trans nasal sphenopalatine ganglion block

Phase

Phase 4

Detailed Description:

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.

Study Type : Interventional
Estimated Enrollment : 75 participants
Masking: Quadruple
Primary Purpose: Treatment
Official Title: Trans-nasal Sphenopalatine Ganglion Block Versus Intravenous Aminophylline Injection for Treatment of Postdural Puncture Headache After Caesarean Section Under Spinal Anesthesia
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 31, 2022
Arm Intervention/treatment

Other: Conservative therapy

will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine

Other: conservative therapy

Active Comparator: Aminophylline

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

Other: conservative therapy

Active Comparator: transnasal spheno-palatine ganglion block

will receive the conservative therapy plus transnasal spheno-palatine ganglion block under strict protective and safety measures against COVID-19, using a hollow cotton swab soaked in lidocaine 2% for 5 minutes in each nostril then 0.5ml of lidocaine 2% will be injected slowly through the hollow swab and repeated once after another 5 minutes where the patient will stay in the supine position for 10 minutes.

Drug: Aminophylline

Ages Eligible for Study: 18 Years to 40 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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.

Postdural Puncture Headache Relief With Aminophylline and SPGB

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Postdural Puncture Headache Relief With Aminophylline and SPGB

How to Participate

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Locations


Not yet recruiting

Egypt,

faculty of medicine, Ain Shams University

Cairo, Egypt, 11591

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