Post-Dural Puncture HeadacheNCT03080610
The Occurrence of Post Dural Puncture Headache After Epidural Blood Patch
An observational study of Post-Dural Puncture Headache, run by Siriraj Hospital at 2 sites in Thailand.
Trial summary
Spinal anesthesia is commonly used for cesarean section.However, the procedure is still have some adverse events such as high spinal block, nerve injuries or postdural puncture headache (PDPH).This is a potential complication of neuraxial anesthesia in clinical practice. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Dural Puncture Headache
- How many people
- 74 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Jan 2006to 1 Dec 2015
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: parturient after received spinal block for cesarean section who have post Dural puncture headache and received epidural blood patch.
Who may be able to join
- parturient after received spinal block for cesarean section who have post Dural puncture headache and received epidural blood patch in Siriraj hospital during 1 January 2006 to 30 December 2015
Who cannot join
- patient who diagnosed post Dural puncture headache from accidental Dural puncture from epidural needle or received combine spinal epidural anesthesia
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Pattrapun Wongsripuemtet
Bangkok, 10240
Pattrapun Wongsripuemtet
Bangkok Noi, Bangkok, 10240
About this study
Official title: Factors Influencing the Occurrence of Post Dural Puncture Headache in Patients Undergoing Cesarean Section After Epidural Blood Patch
Spinal anesthesia is commonly used for cesarean section.However, the procedure is still have some adverse events such as high spinal block, nerve injuries or postdural puncture headache (PDPH).This is a potential complication of neuraxial anesthesia in clinical practice.
The investigators are curious regarding factors determining the incidence of postdural puncture headache in parturients undergoing cesarean section after epidural blood patch.
Read the detailed description
Currently, spinal anesthesia is commonly used for cesarean section in many institutes, since it is a safe technique for both mother and child, with high satisfaction of obstetricians and their colleagues. Bloom, et al. claimed that there was 37,142 women underwent cesarean section in 2002 where 94% was under regional anesthesia, as 40% spinal, 42% epidural and 12% combined spinal and epidural anesthesia.
However, the procedure is inevitable to have some adverse events such as high spinal block, nerve injuries or postdural puncture headache (PDPH) . The PDPH is caused by accidental dura puncture resulting in continuous cerebrospinal fluid (CSF) leakage and gradual intracranial pressure reduction. This is a potential complication of neuraxial anesthesia in clinical practice. The needle characteristics as bevel orientation, stylet reinsertion, an approach, multiple insertion, and operator experience, patient age, history of previous PDPH, body mass index (BMI) > 35 are some responsible factors for the incidence. Chan et al. revealed that amongst 65,348 parturients, the occurence of PDPH was 1.1-1.9%, while Bloom et al. proposed his number as 0.4%. Interestingly, an obstetric meta-analysis showed an incidence of 1.5-11%, caused by spinal needle.
The PDPH is defined as a symptom of severe headache that appears within 7 days following a lumbar puncture. It may be accompanied by other manifestations such as tinnitus, hypoacusis, photophobia, nausea, or neck stiffness. Actually, it can resolve within 1 week or 48 hour after a treatment of blood patch. Other additional treatments include bed rest, analgesics, increase fluid intake, or caffeine containing beverages. In a severe case, a retractable pain might have a good response to intravenous caffeine and epidural blood patch (EBP). Though treatments of PDPH include both pharmacologic and non-pharmacologic regimens, Cochrane review concluded that the EBP was more effective than any other conservative treatments. As a result, the investigators are curious regarding factors determining the incidence of postdural puncture headache in parturients undergoing cesarean section after epidural blood patch.
- Conditions
- Post-Dural Puncture Headache
- Keywords
- Post-Dural Puncture Headache [C10.228.140.546.699.124], Blood Patch, Epidural [E02.319.267.530.580.300.145]
- Medical subject headings
- Post-Dural Puncture Headache
What is being measured
The primary outcome is the main question the study is designed to answer.
The Occurrence of Post Dural Puncture Headache after Epidural Blood Patch
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start1 Jan 2006
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural 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
- Other
- Time perspective
- Other
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pattrapun Wongsripuemtet, Siriraj Hospital
- Investigators
- Ladda Permpolprasert, B.N.S, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080610
- Sponsor's protocol ID
- Si 034/2012
- Status last verified
- Nov 2024
- First submitted
- 3 Mar 2017
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Occurrence of Post Dural Puncture Headache in Patients Undergoing Cesarean Section After Epidural Blood Patch
- ClinicalTrials.gov ID
- NCT03080610
- Acronym / sponsor ID
- Si 034/2012
- Conditions
- Post-Dural Puncture Headache
- Keywords
- Post-Dural Puncture Headache [C10.228.140.546.699.124], Blood Patch, Epidural [E02.319.267.530.580.300.145]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 15 Mar 2017 (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.
Spinal anesthesia is commonly used for cesarean section.However, the procedure is still have some adverse events such as high spinal block, nerve injuries or postdural puncture headache (PDPH).This is a potential complication of neuraxial anesthesia in clinical practice.
The investigators are curious regarding factors determining the incidence of postdural puncture headache in parturients undergoing cesarean section after epidural blood patch.
Detailed description
Currently, spinal anesthesia is commonly used for cesarean section in many institutes, since it is a safe technique for both mother and child, with high satisfaction of obstetricians and their colleagues. Bloom, et al. claimed that there was 37,142 women underwent cesarean section in 2002 where 94% was under regional anesthesia, as 40% spinal, 42% epidural and 12% combined spinal and epidural anesthesia.
However, the procedure is inevitable to have some adverse events such as high spinal block, nerve injuries or postdural puncture headache (PDPH) . The PDPH is caused by accidental dura puncture resulting in continuous cerebrospinal fluid (CSF) leakage and gradual intracranial pressure reduction. This is a potential complication of neuraxial anesthesia in clinical practice. The needle characteristics as bevel orientation, stylet reinsertion, an approach, multiple insertion, and operator experience, patient age, history of previous PDPH, body mass index (BMI) > 35 are some responsible factors for the incidence. Chan et al. revealed that amongst 65,348 parturients, the occurence of PDPH was 1.1-1.9%, while Bloom et al. proposed his number as 0.4%. Interestingly, an obstetric meta-analysis showed an incidence of 1.5-11%, caused by spinal needle.
The PDPH is defined as a symptom of severe headache that appears within 7 days following a lumbar puncture. It may be accompanied by other manifestations such as tinnitus, hypoacusis, photophobia, nausea, or neck stiffness. Actually, it can resolve within 1 week or 48 hour after a treatment of blood patch. Other additional treatments include bed rest, analgesics, increase fluid intake, or caffeine containing beverages. In a severe case, a retractable pain might have a good response to intravenous caffeine and epidural blood patch (EBP). Though treatments of PDPH include both pharmacologic and non-pharmacologic regimens, Cochrane review concluded that the EBP was more effective than any other conservative treatments. As a result, the investigators are curious regarding factors determining the incidence of postdural puncture headache in parturients undergoing cesarean section after epidural blood patch.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- parturient after received spinal block for cesarean section who have post Dural puncture headache and received epidural blood patch.
Key inclusion criteria (1 listed)
- parturient after received spinal block for cesarean section who have post Dural puncture headache and received epidural blood patch in Siriraj hospital during 1 January 2006 to 30 December 2015
Key exclusion criteria (1 listed)
- patient who diagnosed post Dural puncture headache from accidental Dural puncture from epidural needle or received combine spinal epidural 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
The Occurrence of Post Dural Puncture Headache after Epidural Blood Patch
Time frame: 1 year
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 29 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Post-Dural Puncture Headache
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Not yet recruiting
Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
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.
Ladda Permpolprasert, B.N.S principal investigator
Siriraj Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Dural Puncture Headache, run by Siriraj Hospital at 2 sites in Thailand.
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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
The Occurrence of Post Dural Puncture Headache after Epidural Blood Patch (time frame: 1 year). 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 29 Nov 2024.