Post Dural Puncture HeadacheNCT01448590
Post Dural Puncture Headache After Accidental Dural Puncture
An observational study of Post Dural Puncture Headache, run by Sunnybrook Health Sciences Centre.
Trial summary
Epidural anesthesia is associated with potential risks and complications, post dural puncture headache (PDPH) one of the most recognized with epidural or spinal anesthesia. Accidental dural punctures occur with approximately 1.5% of all epidural attempts. 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Mar 2016
- 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: Obstetrical population
Who may be able to join
- any comparative methodology, including case-control studies, cohort studies, randomized clinical trials, and chart reviews.
- Insertion of the epidural catheter into the intrathecal space at the level of dural puncture, was compared to resiting an epidural catheter at another level
Who cannot join
- Any intentional dural punctures (spinal anesthesia) or use of spinal microcatheters were excluded
About this study
Official title: Systematic Review: Post Dural Puncture Headache After Accidental Dural Puncture: Does Insertion of Spinal Catheter Decrease Incidence of Headaches?
Epidural anesthesia is associated with potential risks and complications, post dural puncture headache (PDPH) one of the most recognized with epidural or spinal anesthesia. Accidental dural punctures occur with approximately 1.5% of all epidural attempts. Studies have suggested that the use of an intrathecal catheter reduces the incidence of PDPH. A systematic review of the existing literature will identify if there is reliable evidence to support this theory. A secondary outcome, headache severity, will also be explored via incidence rates of epidural blood patch, as this intervention is performed as a treatment for the most severe headaches.
Read the detailed description
Post dural puncture headache (PDPH) is one of the recognized complications experienced with epidural or spinal anesthesia, resulting from needle puncture of the dura layer of the meninges. This puncture can be deliberate (during spinal anesthesia) or accidental (during epidural anesthesia). Dural punctures allow a leak of cerebrospinal fluid, leading to the characteristic syndrome of PDPH; also known as a spinal headache or low-pressure headache. Accidental dural punctures occur with approximately 1.5% of all epidural attempts. Studies have estimated that, within the obstetrical population, headaches resulting from an inadvertent dural puncture are as high as 50% to 75%.
As the risk of accidental dural punctures (ADP) cannot be eliminated, research has focused on possible interventions that may be taken in order to avoid the onset of a PDPH, eliminate its severity, or treat effects. One of the most common and effective treatments being an epidural blood patch (EBP). More recently, threading the epidural catheter directly into the intrathecal space after the dural puncture has been recognized as a viable option.
- Conditions
- Post Dural Puncture Headache
- Keywords
- post dural puncture headache, accidental dural puncture, PDPH, ADP, spinal catheter, epidural catheter, intrathecal catheter, dural puncture, systemic review
- 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 |
|---|---|---|
| Epidural Resite | After ADP, those patients who receive an epidural resite. | |
| Spinal catheter | After ADP, those who receive the epidural catheter into the spinal space |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of PDPH after epidural resite versus Number of PDPH after insertion of epidural catheter into spinal space
Review of literature that compares two interventions - resiting the epidural or insertion of epidural catheter into spinal space. The Primary outcome measure will be the number of post dural puncture headache events in each group.
Measured: 1 year
Secondary outcomes (1)
What is the incidence of epidural blood patches (EBP)?
Looking at the incidence of EBP in the spinal catheter group, in comparison to the resited epidural group.
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 posted7 Oct 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2016
- Study completionMar 2016
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
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynn Haslam, Sunnybrook Health Sciences Centre
- Investigators
- Lynn Haslam, RN MN/ACNP, Principal investigator, Sunnybrook Health Sciences Centre, TorontoEric Goldszmidt, MD FRCPC, Principal investigator, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448590
- Sponsor's protocol ID
- SHSC-Haslam-PDPH
- Status last verified
- Oct 2016
- First submitted
- 5 Oct 2011
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Review: Post Dural Puncture Headache After Accidental Dural Puncture: Does Insertion of Spinal Catheter Decrease Incidence of Headaches?
- ClinicalTrials.gov ID
- NCT01448590
- Acronym / sponsor ID
- SHSC-Haslam-PDPH
- Conditions
- Post Dural Puncture Headache
- Keywords
- post dural puncture headache, accidental dural puncture, PDPH, ADP, spinal catheter, epidural catheter, intrathecal catheter, dural puncture
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Oct 2011 (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.
Epidural anesthesia is associated with potential risks and complications, post dural puncture headache (PDPH) one of the most recognized with epidural or spinal anesthesia. Accidental dural punctures occur with approximately 1.5% of all epidural attempts. Studies have suggested that the use of an intrathecal catheter reduces the incidence of PDPH. A systematic review of the existing literature will identify if there is reliable evidence to support this theory. A secondary outcome, headache severity, will also be explored via incidence rates of epidural blood patch, as this intervention is performed as a treatment for the most severe headaches.
Detailed description
Post dural puncture headache (PDPH) is one of the recognized complications experienced with epidural or spinal anesthesia, resulting from needle puncture of the dura layer of the meninges. This puncture can be deliberate (during spinal anesthesia) or accidental (during epidural anesthesia). Dural punctures allow a leak of cerebrospinal fluid, leading to the characteristic syndrome of PDPH; also known as a spinal headache or low-pressure headache. Accidental dural punctures occur with approximately 1.5% of all epidural attempts. Studies have estimated that, within the obstetrical population, headaches resulting from an inadvertent dural puncture are as high as 50% to 75%.
As the risk of accidental dural punctures (ADP) cannot be eliminated, research has focused on possible interventions that may be taken in order to avoid the onset of a PDPH, eliminate its severity, or treat effects. One of the most common and effective treatments being an epidural blood patch (EBP). More recently, threading the epidural catheter directly into the intrathecal space after the dural puncture has been recognized as a viable option.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Resite | – | –After ADP, those patients who receive an epidural resite. |
| Spinal catheter | – | –After ADP, those who receive the epidural catheter into the spinal space |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Obstetrical population
Key inclusion criteria (2 listed)
- any comparative methodology, including case-control studies, cohort studies, randomized clinical trials, and chart reviews.
- Insertion of the epidural catheter into the intrathecal space at the level of dural puncture, was compared to resiting an epidural catheter at another level
Key exclusion criteria (1 listed)
- Any intentional dural punctures (spinal anesthesia) or use of spinal microcatheters were excluded
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
Number of PDPH after epidural resite versus Number of PDPH after insertion of epidural catheter into spinal space
Time frame: 1 year
Review of literature that compares two interventions - resiting the epidural or insertion of epidural catheter into spinal space. The Primary outcome measure will be the number of post dural puncture headache events in each group.
1 secondary outcome
What is the incidence of epidural blood patches (EBP)?
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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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.
Lynn Haslam, RN MN/ACNP principal investigator
Sunnybrook Health Sciences Centre, Toronto
Eric Goldszmidt, MD FRCPC principal investigator
Mount Sinai Hospital, Canada
Questions about this trial
What is this clinical trial studying?
An observational study of Post Dural Puncture Headache, run by Sunnybrook Health Sciences Centre.
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 2 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: withdrawn, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of PDPH after epidural resite versus Number of PDPH after insertion of epidural catheter into spinal space (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 13 Oct 2016.