Post Dural Puncture Headache After Accidental Dural Puncture | NCT01448590

Studies
Post Dural Puncture Headache After Accidental Dural Puncture

NCT01448590

Sponsor

Sunnybrook Health Sciences Centre

Status

Withdrawn

Last Update Posted

Oct 13, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Post Dural Puncture Headache

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Oct 5, 2011

First Submission Date that Met QC Criteria

Oct 6, 2011

First Posted Date

Oct 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2016

Last Update Posted Date

Oct 13, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lynn Haslam, Nurse Practitioner, Sunnybrook Health Sciences CentrePrincipal Investigator

Lead Sponsor

Sunnybrook Health Sciences CentreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 year

Secondary Outcomes

Measure	Description	Time Frame
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.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any intentional dural punctures (spinal anesthesia) or use of spinal microcatheters were excluded

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Obstetrical population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lynn Haslam, RN MN/ACNP	Sunnybrook Health Sciences Centre, Toronto	Principal Investigator
Eric Goldszmidt, MD FRCPC	Mount Sinai Hospital, Canada	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051299	Post-Dural Puncture Headache

Ancestor Terms

ID	Term
D051271	Headache Disorders, Secondary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

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Browse Branches

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