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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative therapy | Other | will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine |
|
| Aminophylline | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conservative therapy | Other | bed rest, fluids, abdominal binder, oral paracetamol, and caffeine |
|
| 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 |
| 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 |
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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:
Exclusion Criteria:
Obstetric participant
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| Name | Affiliation | Role |
|---|---|---|
| tamer S abdelaziz, MD | Faculty of medicine, Ain Shams University, Cairo, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of medicine, Ain Shams University | Cairo | 11591 | Egypt |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| D000628 | Aminophylline |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
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| 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% |
|
Recording of adverse effects arrhythmias, agitation, and nasal bleeding.
| at 24 hours |
| D000588 |
| Amines |
| D009930 | Organic Chemicals |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |