Postdural Puncture HeadacheNCT04892290
Sphenopalatine Ganglion Block for Postdural Puncture Headache
An observational study of Postdural Puncture Headache, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Background: Postdural puncture headache (PDPH), which is one of the complications of spinal anesthesia, is a condition that negatively affects the quality of life of patients, causes late mobilization and prolonged hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postdural Puncture Headache
- What is being tested?
- Conservative Treatment for Postdural Puncture Headache
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 19 May 2020
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Postdural Puncture Headache patients
Who may be able to join
- 18-65 years-old
- not having any headache diagnosis (G44 and subgroup according to the International Classification of Diseases-10 classification),
- developed PDPH according to the International Headaches Classification after the neuraxial procedure
Who cannot join
- history of primary headaches such as migraine, cluster type, tension type
- secondary headache such as preeclampsia / eclampsia, cerebral venous thrombosis, stroke, ruptured aneurysm, hypertensive encephalopathy, pituitary apoplexy, meningitis and subarachnoid hemorrhage
- any local or systemic infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Sakarya, 54290
About this study
Official title: Effectiveness of Sphenopalatine Ganglion Block on Postdural Puncture Headache Treatment: A Retrospective Observational Study
Background: Postdural puncture headache (PDPH), which is one of the complications of spinal anesthesia, is a condition that negatively affects the quality of life of patients, causes late mobilization and prolonged hospital stay. Sphenopalatine ganglion block (SGB) has created a minimally invasive, easy, and safe treatment alternative.
Objective: Evaluating the effectiveness of topical SGB on PDPH treatment. Design: Retrospective observational study Setting: Single center tertiary level of care hospital study. The files of PDPH patients between Jan 2018 and Jan 2020 were scanned.
Read more
Patients: PDPH patients aged 18-65 are included and any patients with primary/secondary headache history are excluded.
Main outcome measures: Patients were divided into 2 groups. The group that given only conservative treatment was named as Group C, and the group of patients who had additionally been applied SGB was named as Group SGB. Headache severity was measured with Visual Analogue Scale (VAS) at the 1st,3rd, 12th and 24th hours of the treatment, in supine and upright position.
- Conditions
- Postdural Puncture Headache
- Being tested
- Conservative Treatment for Postdural Puncture Headache
- Keywords
- Sphenopalatine Ganglion Block, Postdural Puncture Headache
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative Treatment for Postdural Puncture HeadacheOther
Also called Sphenopalatine Ganglion Block
The patients in Group C were given continuous bed rest in the supine position, 3000 mL daily hydration, 6 mg kg-1 aminophylline , 2 g day-1 paracetamol and 65 mg day-1 caffeine as conservative treatment. Topical SGB was applied to patients in Group SGB in addition to conservative treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Postdural puncture headache patients treated with Conservative treatment Receives: Other: Conservative Treatment for Postdural Puncture Headache | |
| Group SGB | Postdural puncture headache patients treated with Sphenopalatine Ganglion Block and conservative treatment Receives: Other: Conservative Treatment for Postdural Puncture Headache |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache in Supine Position
Headache severity changes with Visual Analogue Scale (VAS, 0-10, 0: no pain, 10:worst pain)
Measured: 1st, 3rd, 12th and 24th hours of follow-up
Secondary outcomes (2)
Headache in Prone Position
Headache severity changes with Visual Analogue Scale (VAS, 0-10, 0: no pain, 10:worst pain)
Measured: 1st, 3rd, 12th and 24th hours of follow-up
Successfully treated patients ratio
At the 24th hour of their follow-up, all patients with a VAS>3 (Visual Analogue Scale) headache in an upright position are considered as unsuccessful treatment and are directed to the epidural blood patch procedure. Both groups will be compared with successfully treated patients ratios.
Measured: 24th hour of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Dec 2019
- Primary completion30 Apr 2020
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Kaya, Sakarya University
- Investigators
- Burak Kaya, MD, Principal investigator, Sakarya UniversitySerbülent Gökhan Beyaz, Prof MD, Study chair, Istinye UniversityAyça Taş Tuna, As Prof MD, Study chair, Sakarya UniversityHavva Kocayiğit, MD, Study chair, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892290
- Sponsor's protocol ID
- 71522473/050.01.04
- Status last verified
- May 2021
- First submitted
- 14 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Database
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sphenopalatine Ganglion Block on Postdural Puncture Headache Treatment: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT04892290
- Acronym / sponsor ID
- 71522473/050.01.04
- Conditions
- Postdural Puncture Headache
- Keywords
- Sphenopalatine Ganglion Block, Postdural Puncture Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 19 May 2021 (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.
Background: Postdural puncture headache (PDPH), which is one of the complications of spinal anesthesia, is a condition that negatively affects the quality of life of patients, causes late mobilization and prolonged hospital stay. Sphenopalatine ganglion block (SGB) has created a minimally invasive, easy, and safe treatment alternative.
Objective: Evaluating the effectiveness of topical SGB on PDPH treatment. Design: Retrospective observational study Setting: Single center tertiary level of care hospital study. The files of PDPH patients between Jan 2018 and Jan 2020 were scanned.
Patients: PDPH patients aged 18-65 are included and any patients with primary/secondary headache history are excluded.
Main outcome measures: Patients were divided into 2 groups. The group that given only conservative treatment was named as Group C, and the group of patients who had additionally been applied SGB was named as Group SGB. Headache severity was measured with Visual Analogue Scale (VAS) at the 1st,3rd, 12th and 24th hours of the treatment, in supine and upright position.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | – | Other: Conservative Treatment for Postdural Puncture HeadachePostdural puncture headache patients treated with Conservative treatment |
| Group SGB | – | Other: Conservative Treatment for Postdural Puncture HeadachePostdural puncture headache patients treated with Sphenopalatine Ganglion Block and conservative treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postdural Puncture Headache patients
Key inclusion criteria (3 listed)
- 18-65 years-old
- not having any headache diagnosis (G44 and subgroup according to the International Classification of Diseases-10 classification),
- developed PDPH according to the International Headaches Classification after the neuraxial procedure
Key exclusion criteria (3 listed)
- history of primary headaches such as migraine, cluster type, tension type
- secondary headache such as preeclampsia / eclampsia, cerebral venous thrombosis, stroke, ruptured aneurysm, hypertensive encephalopathy, pituitary apoplexy, meningitis and subarachnoid hemorrhage
- any local or systemic infection
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 Treatment for Postdural Puncture HeadacheAlso: Sphenopalatine Ganglion BlockThe patients in Group C were given continuous bed rest in the supine position, 3000 mL daily hydration, 6 mg kg-1 aminophylline , 2 g day-1 paracetamol and 65 mg day-1 caffeine as conservative treatment. Topical SGB was applied to patients in Group SGB in addition to conservative treatment. | Other | Group C, Group SGB |
Primary outcome
Headache in Supine Position
Time frame: 1st, 3rd, 12th and 24th hours of follow-up
Headache severity changes with Visual Analogue Scale (VAS, 0-10, 0: no pain, 10:worst pain)
2 secondary outcomes
Headache in Prone Position
Time frame: 1st, 3rd, 12th and 24th hours of follow-up
Successfully treated patients ratio
Time frame: 24th hour of follow-up
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 19 May 2021.
- Individual participant dataSharing planned: Undecided. Database
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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.
Burak Kaya, MD principal investigator
Sakarya University
Serbülent Gökhan Beyaz, Prof MD study chair
Istinye University
Ayça Taş Tuna, As Prof MD study chair
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postdural Puncture Headache, run by Sakarya University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 19 May 2021. 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 Turkey (Türkiye). 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.
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?
Headache in Supine Position (time frame: 1st, 3rd, 12th and 24th hours of follow-up). 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 19 May 2021.