Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT05552404
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05552404
Study Brief:
Protocol Section:
NCT05552404