AnesthesiaPhase 4NCT05552404
Postdural Puncture Headache Relief With Aminophylline and SPGB
A Phase 4 study testing conservative therapy, Aminophylline and trans nasal sphenopalatine ganglion block in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of the study is to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- conservative therapy, Aminophylline and trans nasal sphenopalatine ganglion block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trans-nasal Sphenopalatine Ganglion Block Versus Intravenous Aminophylline Injection for Treatment of Postdural Puncture Headache After Caesarean Section Under Spinal Anesthesia
The purpose of the study is to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.
Read the 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
- Being tested
- conservative therapy, Aminophylline, trans nasal sphenopalatine ganglion block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative therapyOther
bed rest, fluids, abdominal binder, oral paracetamol, and caffeine
AminophyllineDrug
conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)
trans nasal sphenopalatine ganglion blockProcedure or surgery
conservative therapy plus sphenopalatine ganglion block SPGB using hollow cotton swab and lidocaine 2%
| Study group | Role | What they receive |
|---|---|---|
| Conservative therapy | Other | will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine Receives: 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) Receives: Other: conservative therapy; Drug: 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. Receives: Other: conservative therapy; Procedure: trans nasal sphenopalatine ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.
0 - no pain to 10 - worst pain imaginable
Measured: at 12 hours
Secondary outcomes (2)
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.
Measured: at 24 hours
Adverse effects
Recording of adverse effects arrhythmias, agitation, and nasal bleeding.
Measured: at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Oct 2022
- Primary completion30 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Samir Abdelsalam, Ain Shams University
- Investigators
- tamer S abdelaziz, MD, Principal investigator, Faculty of medicine, Ain Shams University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552404
- Sponsor's protocol ID
- FMASU R 124/ 2022
- Status last verified
- Jan 2023
- First submitted
- 16 Sep 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-nasal Sphenopalatine Ganglion Block Versus Intravenous Aminophylline Injection for Treatment of Postdural Puncture Headache After Caesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05552404
- Acronym / sponsor ID
- FMASU R 124/ 2022
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative therapy | Other | Other: conservative therapywill receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine |
| Aminophylline | Active comparator | Other: conservative therapy, Drug: Aminophyllinewill receive conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes) |
| transnasal spheno-palatine ganglion block | Active comparator | Other: conservative therapy, Procedure: trans nasal sphenopalatine ganglion blockwill 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conservative therapybed rest, fluids, abdominal binder, oral paracetamol, and caffeine | Other | Aminophylline, Conservative therapy, transnasal spheno-palatine ganglion block |
| Aminophyllineconservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes) | Drug | Aminophylline |
| trans nasal sphenopalatine ganglion blockconservative therapy plus sphenopalatine ganglion block SPGB using hollow cotton swab and lidocaine 2% | Procedure or surgery | transnasal spheno-palatine ganglion block |
Primary outcome
the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.
Time frame: at 12 hours
0 - no pain to 10 - worst pain imaginable
2 secondary outcomes
Patient Global impression of change (PGIC) scale
Time frame: at 24 hours
Adverse effects
Time frame: at 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tamer S abdelaziz, MD principal investigator
Faculty of medicine, Ain Shams University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing conservative therapy, Aminophylline and trans nasal sphenopalatine ganglion block in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment. (time frame: at 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.