PregnancyNCT02122419
The Effect of Patient Position on Postdural Puncture Headache
An observational study of Pregnancy and Headache, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
We aimed to investigate the association between the position in which spinal anesthesia was performed and postdural puncture headache occurrence. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- lateral and sitting
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 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: Patients records form patients who experienced headache after caesarean section with spinal anesthesia were retrospectively evaluated
Who may be able to join
- Patients older than 18 years were included
Who cannot join
- Conversion to general anesthesia was the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dışkapı Yıldırım Beyazıt Education and Research Hospital
Ankara, Ankara, 06110
About this study
Official title: Phase IV Study of Application Position During Spinal Anesthesia
We aimed to investigate the association between the position in which spinal anesthesia was performed and postdural puncture headache occurrence.
Read the detailed description
Records of patients who underwent caesarean section between January, 2013 and November, 2013 with spinal anesthesia will be retrospectively examined. Demographic data of patients, comorbid diseases, position of patient while performing spinal anesthesia, the number of spinal puncture attempts will be recorded.
- Being tested
- lateral, sitting
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateralOther
spinal anesthesia performed during lateral position
sittingOther
spinal anesthesia performed during sitting position
| Study group | Role | What they receive |
|---|---|---|
| lateral | spinal anesthesia performed during lateral position Receives: Other: lateral | |
| sitting | spinal anesthesia performed during sitting position Receives: Other: sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
postdural puncture headache
patient records will be evaluated regarding post dural puncture headache
Measured: postoperative first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- 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, Ministery of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122419
- Sponsor's protocol ID
- PDPHPOSITION
- Status last verified
- Aug 2015
- First submitted
- 22 Apr 2014
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dogan M, Turker H, Ugurlu M, Ergun F, Bozkurt M. Do peroperative supine and prone positions have an effect on postspinal headache incidence? Neurosciences (Riyadh). 2005 Jan;10(1):64-7.
PubMed 22473188Gil NS, Lee JH, Yoon SZ, Jeon Y, Lim YJ, Bahk JH. Comparison of thoracic epidural pressure in the sitting and lateral decubitus positions. Anesthesiology. 2008 Jul;109(1):67-71. doi: 10.1097/ALN.0b013e31817b80df.
PubMed 18580174Abel AS, Brace JR, McKinney AM, Friedman DI, Smith SD, Westesson PL, Nascene D, Ott F, Lee MS. Effect of patient positioning on cerebrospinal fluid opening pressure. J Neuroophthalmol. 2014 Sep;34(3):218-22. doi: 10.1097/WNO.0000000000000074.
PubMed 24213568
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 Application Position During Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02122419
- Acronym / sponsor ID
- PDPHPOSITION
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Apr 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.
We aimed to investigate the association between the position in which spinal anesthesia was performed and postdural puncture headache occurrence.
Detailed description
Records of patients who underwent caesarean section between January, 2013 and November, 2013 with spinal anesthesia will be retrospectively examined. Demographic data of patients, comorbid diseases, position of patient while performing spinal anesthesia, the number of spinal puncture attempts will be recorded.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lateral | – | Other: lateralspinal anesthesia performed during lateral position |
| sitting | – | Other: sittingspinal anesthesia performed during sitting position |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients records form patients who experienced headache after caesarean section with spinal anesthesia were retrospectively evaluated
Key inclusion criteria (1 listed)
- Patients older than 18 years were included
Key exclusion criteria (1 listed)
- Conversion to general anesthesia was the exclusion criteria.
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 |
|---|---|---|
| lateralspinal anesthesia performed during lateral position | Other | lateral |
| sittingspinal anesthesia performed during sitting position | Other | sitting |
Primary outcome
postdural puncture headache
Time frame: postoperative first day
patient records will be evaluated regarding post dural puncture headache
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 22473188Dogan M, Turker H, Ugurlu M, Ergun F, Bozkurt M. Do peroperative supine and prone positions have an effect on postspinal headache incidence? Neurosciences (Riyadh). 2005 Jan;10(1):64-7.
- Background: PubMed 18580174Gil NS, Lee JH, Yoon SZ, Jeon Y, Lim YJ, Bahk JH. Comparison of thoracic epidural pressure in the sitting and lateral decubitus positions. Anesthesiology. 2008 Jul;109(1):67-71. doi: 10.1097/ALN.0b013e31817b80df.
- Background: PubMed 24213568Abel AS, Brace JR, McKinney AM, Friedman DI, Smith SD, Westesson PL, Nascene D, Ott F, Lee MS. Effect of patient positioning on cerebrospinal fluid opening pressure. J Neuroophthalmol. 2014 Sep;34(3):218-22. doi: 10.1097/WNO.0000000000000074.
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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.
ibrahim öztürk, M.D principal investigator
Ministery of Health
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 Pregnancy and 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 first day). 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 NCT02122419, which also lists 3 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.