A Phase 4 interventional study of conservative therapy and Aminophylline in Anesthesia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
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.
125 studies on the registry are indexed under Post-Dural Puncture Headache; 25 are open to participants now.
This study's enrollment of 75 is close to the median of 80 across 82 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
PDPH was defined according to the international classification of headache disorders, 3rd edition criteria (ICHD-3) as:
Exclusion Criteria:
will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine
Other: conservative therapy
will receive conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)
Other: conservative therapy · Drug: Aminophylline
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 · Procedure: trans nasal sphenopalatine ganglion block
bed rest, fluids, abdominal binder, oral paracetamol, and caffeine
conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)
conservative therapy plus sphenopalatine ganglion block SPGB using hollow cotton swab and lidocaine 2%
the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.
0 - no pain to 10 - worst pain imaginable
Time frame: at 12 hours
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.
Time frame: at 24 hours
Adverse effects
Recording of adverse effects arrhythmias, agitation, and nasal bleeding.
Time frame: at 24 hours
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Ain Shams University