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Postdural Puncture Headache Relief With Aminophylline and SPGB

Primary Purpose

Anesthesia

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
conservative therapy
Aminophylline
trans nasal sphenopalatine ganglion block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • faculty of medicine, Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Conservative therapy

Aminophylline

transnasal spheno-palatine ganglion block

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2022
Last Updated
January 10, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05552404
Brief Title
Postdural Puncture Headache Relief With Aminophylline and SPGB
Official Title
Trans-nasal Sphenopalatine Ganglion Block Versus Intravenous Aminophylline Injection for Treatment of Postdural Puncture Headache After Caesarean Section Under Spinal Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative therapy
Arm Type
Other
Arm Description
will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine
Arm Title
Aminophylline
Arm Type
Active Comparator
Arm Description
will receive conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)
Arm Title
transnasal spheno-palatine ganglion block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
conservative therapy
Intervention Description
bed rest, fluids, abdominal binder, oral paracetamol, and caffeine
Intervention Type
Drug
Intervention Name(s)
Aminophylline
Intervention Description
conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)
Intervention Type
Procedure
Intervention Name(s)
trans nasal sphenopalatine ganglion block
Intervention Description
conservative therapy plus sphenopalatine ganglion block SPGB using hollow cotton swab and lidocaine 2%
Primary Outcome Measure Information:
Title
the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.
Description
0 - no pain to 10 - worst pain imaginable
Time Frame
at 12 hours
Secondary Outcome Measure Information:
Title
Patient Global impression of change (PGIC) scale
Description
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
Title
Adverse effects
Description
Recording of adverse effects arrhythmias, agitation, and nasal bleeding.
Time Frame
at 24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Obstetric participant
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tamer S abdelaziz, MD
Organizational Affiliation
Faculty of medicine, Ain Shams University, Cairo, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine, Ain Shams University
City
Cairo
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

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Postdural Puncture Headache Relief With Aminophylline and SPGB

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