Postdural Puncture Headache Relief With Aminophylline and SPGB

NCT ID: NCT05552404

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2022-12-31

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Conservative therapy

will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine

Group Type: OTHER

conservative therapy

Intervention Type: OTHER

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

Aminophylline

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

Group Type: ACTIVE_COMPARATOR

conservative therapy

Intervention Type: OTHER

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

Aminophylline

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

conservative therapy

Intervention Type: OTHER

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

trans nasal sphenopalatine ganglion block

Intervention Type: PROCEDURE

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

Interventions

conservative therapy

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

Intervention Type: OTHER

Aminophylline

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

Intervention Type: DRUG

trans nasal sphenopalatine ganglion block

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Tamer Samir Abdelsalam

lecturer of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

tamer S abdelaziz, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine, Ain Shams University, Cairo, Egypt

Locations

faculty of medicine, Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R 124/ 2022

Identifier Type: -

Identifier Source: org_study_id