Postdural Puncture Headache Relief With Aminophylline and SPGB

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Other: conservative therapy; Procedure: trans nasal sphenopalatine ganglion block; Drug: Aminophylline

• Registration Number: NCT05552404
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-23
• Study Start: 2022-10-01
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative therapy	conservative therapy	will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine
Aminophylline	conservative therapy	will receive conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)
transnasal spheno-palatine ganglion block	trans nasal sphenopalatine 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.
transnasal spheno-palatine ganglion block	conservative therapy	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.
Aminophylline	Aminophylline	will receive conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)

Primary Outcome Measures

Name	Time	Method
the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.	at 12 hours	0 - no pain to 10 - worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Patient Global impression of change (PGIC) scale	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.
Adverse effects	at 24 hours	Recording of adverse effects arrhythmias, agitation, and nasal bleeding.

Trial Locations

Locations (1)

faculty of medicine, Ain Shams University; 🇪🇬 Cairo, Egypt