Postdural Puncture Headache Relief With Aminophylline and SPGB

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Procedure: trans nasal sphenopalatine ganglion block; Other: conservative therapy; Drug: Aminophylline

Study type: Interventional

Funder types: Other

Identifiers

NCT05552404

FMASU R 124/ 2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups

Conservative therapy

Other group

Description:

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

Treatment:

Other: conservative therapy

Aminophylline

Active Comparator group

Description:

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

Treatment:

Other: conservative therapy

Drug: Aminophylline

transnasal spheno-palatine ganglion block

Active Comparator group

Description:

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.

Treatment:

Procedure: trans nasal sphenopalatine ganglion block

Other: conservative therapy