Ain Shams University
Tamer Samir Abdelsalam
The purpose of the study is to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.
Anesthesia
conservative therapy
Aminophylline
trans nasal sphenopalatine ganglion block
Phase 4
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 Type : | Interventional |
Estimated Enrollment : | 75 participants |
Masking: | Quadruple |
Primary Purpose: | Treatment |
Official Title: | Trans-nasal Sphenopalatine Ganglion Block Versus Intravenous Aminophylline Injection for Treatment of Postdural Puncture Headache After Caesarean Section Under Spinal Anesthesia |
Actual Study Start Date : | October 1, 2022 |
Estimated Primary Completion Date : | December 30, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
---|---|
Other: Conservative therapy will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine |
Other: conservative therapy |
Active Comparator: Aminophylline will receive conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes) |
Other: conservative therapy |
Active Comparator: transnasal spheno-palatine 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. |
Drug: Aminophylline |
Ages Eligible for Study: | 18 Years to 40 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
faculty of medicine, Ain Shams University
Cairo, Egypt, 11591