Postdural Puncture HeadacheNCT02150304
Aminophylline Prophylaxis For Postdural Puncture Headache
An observational study of Postdural Puncture Headache, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
postdural puncture headache is a rare but serious complication of spinal anesthesia. many drugs were studied in prevention or treatment of that complication. However, there are limited numbers of trials about intravenous aminophylline for prevention. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postdural Puncture Headache
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jun 2014
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: patient records form who experinced headache after caserean section with spinal anesthesia were retrospectively evaluated
Who may be able to join
- patients aolder than 18 years old
Who cannot join
- conversion to general anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dışkapı Yıldırım Beyazıt Education and Research Hospital
Ankara, 06110
About this study
Official title: Phase IV Study of Intravenous Aminophylline During Spinal Anesthesia
postdural puncture headache is a rare but serious complication of spinal anesthesia. many drugs were studied in prevention or treatment of that complication. However, there are limited numbers of trials about intravenous aminophylline for prevention. because of that we retrospectively aimed to investigate the effectiveness of aminophylline for postdural puncture headache in cesarean section.
Read the detailed description
retrospective trial about the effect of intravenous aminophylline for prevention of PDPH after caserean section with spinal anesthesia
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| intravenous aminophylline | intravenous aminophylline use during spinal anesthesia | |
| no intravenous aminophylline | no use of intravenous aminophylline during spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postdural puncture headache
Measured: postoperative 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İBRAHİM ÖZTÜRK, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- ibrahim öztürk, M.D., Principal investigator, dışkapı yıldırım beyazıt education and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150304
- Sponsor's protocol ID
- PDPHAMINOPHYLLINE
- Status last verified
- Aug 2015
- First submitted
- 24 May 2014
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Naghibi K, Hamidi M. Prophylactic administration of aminophylline plus dexamethasone reduces post-dural puncture headache better than using either drug alone in patients undergoing lower extremity surgery. Adv Biomed Res. 2014 Jan 9;3:5. doi: 10.4103/2277-9175.124631. eCollection 2014.
PubMed 24600595Basurto Ona X, Uriona Tuma SM, Martinez Garcia L, Sola I, Bonfill Cosp X. Drug therapy for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD001792. doi: 10.1002/14651858.CD001792.pub3.
PubMed 23450533
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Intravenous Aminophylline During Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02150304
- Acronym / sponsor ID
- PDPHAMINOPHYLLINE
- Conditions
- Postdural Puncture Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 May 2014 (estimated)
- 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.
postdural puncture headache is a rare but serious complication of spinal anesthesia. many drugs were studied in prevention or treatment of that complication. However, there are limited numbers of trials about intravenous aminophylline for prevention. because of that we retrospectively aimed to investigate the effectiveness of aminophylline for postdural puncture headache in cesarean section.
Detailed description
retrospective trial about the effect of intravenous aminophylline for prevention of PDPH after caserean section with spinal anesthesia
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous aminophylline | – | –intravenous aminophylline use during spinal anesthesia |
| no intravenous aminophylline | – | –no use of intravenous aminophylline during spinal anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patient records form who experinced headache after caserean section with spinal anesthesia were retrospectively evaluated
Key inclusion criteria (1 listed)
- patients aolder than 18 years old
Key exclusion criteria (1 listed)
- conversion to general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postdural puncture headache
Time frame: postoperative 2 weeks
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 5 Aug 2015.
- Background: PubMed 24600595Naghibi K, Hamidi M. Prophylactic administration of aminophylline plus dexamethasone reduces post-dural puncture headache better than using either drug alone in patients undergoing lower extremity surgery. Adv Biomed Res. 2014 Jan 9;3:5. doi: 10.4103/2277-9175.124631. eCollection 2014.
- Background: PubMed 23450533Basurto Ona X, Uriona Tuma SM, Martinez Garcia L, Sola I, Bonfill Cosp X. Drug therapy for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD001792. doi: 10.1002/14651858.CD001792.pub3.
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Comparison of Nebulized Neostigmine/Atropine Versus Lignocaine in Treating Acute Post-dural Puncture Headache Following Subarachnoid Block in Parturient Undergoing Elective Cesarean Section. A Randomized, Clinical Trial.
Post-Dural Puncture Headache
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.
ibrahim öztürk, M.D. principal investigator
dışkapı yıldırım beyazıt education and research hospital
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 Diskapi Yildirim Beyazit Education and Research Hospital 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 1 inclusion and 1 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 5 Aug 2015. 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?
postdural puncture headache (time frame: postoperative 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150304, which also lists 2 linked publications.
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 5 Aug 2015.