Postdural Puncture Headache Relief With Aminophylline and SPGB

Trans-nasal Sphenopalatine Ganglion Block Versus Intravenous Aminophylline Injection for Treatment of Postdural Puncture Headache After Caesarean Section Under Spinal Anesthesia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05552404

Enrollment

Registered

2022-09-23

Start date

2022-10-01

Completion date

2022-12-31

Last updated

2023-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

The purpose of the study is to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.

Detailed description

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.

Interventions

OTHERconservative therapy

bed rest, fluids, abdominal binder, oral paracetamol, and caffeine

DRUGAminophylline

conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)

PROCEDUREtrans nasal sphenopalatine ganglion block

conservative therapy plus sphenopalatine ganglion block SPGB using hollow cotton swab and lidocaine 2%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.	at 12 hours	0 - no pain to 10 - worst pain imaginable

Secondary

Measure	Time frame	Description
Patient Global impression of change (PGIC) scale	at 24 hours	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.
Adverse effects	at 24 hours	Recording of adverse effects arrhythmias, agitation, and nasal bleeding.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026