Postdural Puncture Headache Relief With Aminophylline and SPGB

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

Detailed Description
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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.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Other: conservative therapy
* Drug: Aminophylline
* Procedure: trans nasal sphenopalatine ganglion block


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conservative therapy<br>will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine | Other: conservative therapy<br>* bed rest, fluids, abdominal binder, oral paracetamol, and caffeine<br>|
| Active Comparator: Aminophylline<br>will receive conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes) | Other: conservative therapy<br>* bed rest, fluids, abdominal binder, oral paracetamol, and caffeine<br>Drug: Aminophylline<br>* conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)<br>|
| Active Comparator: transnasal spheno-palatine ganglion block<br>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. | Other: conservative therapy<br>* bed rest, fluids, abdominal binder, oral paracetamol, and caffeine<br>Procedure: trans nasal sphenopalatine ganglion block<br>* conservative therapy plus sphenopalatine ganglion block SPGB using hollow cotton swab and lidocaine 2%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment. | 0 - no pain to 10 - worst pain imaginable | at 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global impression of change (PGIC) scale | 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. | at 24 hours | 
| Adverse effects | Recording of adverse effects arrhythmias, agitation, and nasal bleeding. | at 24 hours |