Postdural Puncture Headache Relief With Aminophylline and SPGB

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05552404
• Other study ID #: FMASU R 124/ 2022
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Headache
• Post-Dural Puncture Headache

Intervention

Other:
• conservative therapy
bed rest, fluids, abdominal binder, oral paracetamol, and caffeine

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

Procedure:
• trans nasal sphenopalatine ganglion block
conservative therapy plus sphenopalatine ganglion block SPGB using hollow cotton swab and lidocaine 2%

Locations

Country	Name	City	State
Egypt	faculty of medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.	0 - no pain to 10 - worst pain imaginable	at 12 hours
Secondary	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.	at 24 hours
Secondary	Adverse effects	Recording of adverse effects arrhythmias, agitation, and nasal bleeding.	at 24 hours