Postdural Puncture Headache Relief With Aminophylline and SPGB

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05552404
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Actual Duration (Months): 3
• Patients Per Site Per Month: 25.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Other: conservative therapy; Drug: Aminophylline; Procedure: trans nasal sphenopalatine ganglion block	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• 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: Oct 1, 2022
• Actual Primary Completion Date: Dec 30, 2022
• Actual Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Conservative therapy will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine	Other: conservative therapy; bed rest, fluids, abdominal binder, oral paracetamol, and caffeine
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; 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)
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.	Other: conservative therapy; bed rest, fluids, abdominal binder, oral paracetamol, and caffeine; Procedure: trans nasal sphenopalatine ganglion block; conservative therapy plus sphenopalatine ganglion block SPGB using hollow cotton swab and lidocaine 2%

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. Adverse effects [at 24 hours]

   Recording of adverse effects arrhythmias, agitation, and nasal bleeding.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of medicine, Ain Shams University	Cairo		Egypt	11591

Sponsors and Collaborators

• Ain Shams University

Investigators

• Principal Investigator: tamer S abdelaziz, MD, Faculty of medicine, Ain Shams University, Cairo, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tamer Samir Abdelsalam, lecturer of Anesthesia, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05552404
• Other Study ID Numbers: FMASU R 124/ 2022
• First Posted: Sep 23, 2022
• Last Update Posted: Jan 11, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Post-Dural Puncture Headache; Headache; Aminophylline

Study Results

No Results Posted as of Jan 11, 2023