NCT05552404

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

September 16, 2022

Last Update Submit

January 10, 2023

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Patient Global impression of change (PGIC) scale

    at 24 hours

  • Adverse effects

    at 24 hours

Study Arms (3)

Conservative therapy

OTHER

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

Other: conservative therapy

Aminophylline

ACTIVE COMPARATOR

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

Other: conservative therapyDrug: Aminophylline

transnasal spheno-palatine ganglion block

ACTIVE COMPARATOR

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 therapyProcedure: trans nasal sphenopalatine ganglion block

Interventions

conservative therapyOTHER

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

AminophyllineConservative therapytransnasal spheno-palatine ganglion block
AminophyllineDRUG

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

Aminophylline
trans nasal sphenopalatine ganglion blockPROCEDURE

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

transnasal spheno-palatine ganglion block

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsObstetric participant
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine, Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

Conservative TreatmentAminophylline

Intervention Hierarchy (Ancestors)

TherapeuticsEthylenediaminesDiaminesPolyaminesAminesOrganic ChemicalsTheophyllineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • tamer S abdelaziz, MD

    Faculty of medicine, Ain Shams University, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Anesthesia

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 23, 2022

Study Start

October 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 31, 2022

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

EG(1)