Postdural Puncture Headache Relief With Aminophylline and SPGB (NCT05552404) | Clinical Trial Compass
CompletedPhase 4
Postdural Puncture Headache Relief With Aminophylline and SPGB
Egypt75 participantsStarted 2022-10-01
Plain-language summary
The purpose of the study is to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.