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Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache (UpSideDown)

Primary Purpose

Post-Dural Puncture Headache

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prone position for 1 hour after blood patch
Blood patch
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-Dural Puncture Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient was informed about the implementation of the study, its objectives, constraints and patient rights
  • The patient has signed the informed consent
  • The patient must be affiliated or beneficiary of a health insurance plan
  • The patient is available for follow up concerning her hospital stay
  • The patient has a post-dural puncture headache after a vaginal delivery. The diagnosis of post-puncture headache is retained on the basis of a frankly postural character for the headache, triggered or exacerbated by orthostatic position and relieved by recumbency.
  • The patient has an indication for a blood patch

Exclusion Criteria:

  • The patient is participating in another interventional study, with the exception of the following studies: Papillo PMA (2013-A00538-37); DG-Postpartum (2013-A00277-38); ElastoMAP (2013-A01148-37); ElastoDéclench (2014-A00828-39); LXRs(2009-A00968-49); OASIS II (2013-A00773-42); GrossPath (2014-A01120-47).
  • The patient is in an exclusion period determined by a previous study
  • The patient is under guardianship, curatorship or under judicial protection
  • The patient refuses to sign the consent
  • It is not possible correctly inform the patient
  • The patient is pregnant
  • The patient has a contra-indication (or an incompatible combination therapy) for a necessary treatment in this study
  • The patient was delivered by cesarean section

Sites / Locations

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The study population

Arm Description

The study population consists of adult women requiring an epidural blood patch for the treatment of post-dural puncture headache following vaginal delivery. Women who delivered by cesarean section are not included due to the discomfort of the prone position while there is an abdominal scar. Intervention: Prone position for 1 hour after blood patch

Outcomes

Primary Outcome Measures

Headache recurrence: yes/no
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
Headache recurrence: yes/no
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
Headache recurrence: yes/no
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby

Secondary Outcome Measures

The number of blood patches required for each patient
Visual analog scale for pain
Scale from 0.0 to 10.0.
Visual analog scale for pain
Scale from 0.0 to 10.0.
Visual analog scale for pain
Scale from 0.0 to 10.0.
Visual analog scale for pain
Scale from 0.0 to 10.0.
Presence/absence of complications
Presence / absence of the following complications: nerve paresthesia; nerve damage; accidental dural puncture; subcutaneous hematoma at the puncture site; meningitis; epidural abscess; localized infection at the puncture site; encephalopathy; cerebral venous thrombosis; subdural hematoma
In case of recurrence of headache following the 1st blood patch, the presence / absence of the following accompanying symptoms: nausea; vomiting; dizziness; tinnitus; diplopia; photophobia; low back pain.

Full Information

First Posted
April 20, 2015
Last Updated
January 30, 2017
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02427009
Brief Title
Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache
Acronym
UpSideDown
Official Title
Effectiveness of Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
no inclusion
Study Start Date
December 2015 (undefined)
Primary Completion Date
April 21, 2016 (Actual)
Study Completion Date
April 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to assess the rate of recurrence of headache following a first blood patch where patients will be positioned in the prone position for an hour after each blood patch needed during this study.
Detailed Description
The secondary objectives of this study are to: A. To evaluate the number of blood patches needed for each patient during her hospital stay B. Assessing the intensity of all headaches every 24H C. Evaluate the complications occurring during the hospital stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The study population
Arm Type
Experimental
Arm Description
The study population consists of adult women requiring an epidural blood patch for the treatment of post-dural puncture headache following vaginal delivery. Women who delivered by cesarean section are not included due to the discomfort of the prone position while there is an abdominal scar. Intervention: Prone position for 1 hour after blood patch
Intervention Type
Other
Intervention Name(s)
Prone position for 1 hour after blood patch
Intervention Description
After performing a blood patch, the patient will be placed in a prone position for 1 hour. This applies to all blood patches required during her hospitalization.
Intervention Type
Procedure
Intervention Name(s)
Blood patch
Intervention Description
And indicated in inclusion criteria, patients in this protocol will have at least 1 blood patch. The amount of blood to be injected into the peridural space is fixed at 20 ml, but can be less in case of pain.
Primary Outcome Measure Information:
Title
Headache recurrence: yes/no
Description
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
Time Frame
24 hours after first blood patch
Title
Headache recurrence: yes/no
Description
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
Time Frame
48 hours after first blood patch
Title
Headache recurrence: yes/no
Description
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
Time Frame
72 hours after first blood patch
Secondary Outcome Measure Information:
Title
The number of blood patches required for each patient
Time Frame
Hospital discharge (expected average of 7 days)
Title
Visual analog scale for pain
Description
Scale from 0.0 to 10.0.
Time Frame
Baseline (day 0)
Title
Visual analog scale for pain
Description
Scale from 0.0 to 10.0.
Time Frame
24 hours after blood patch
Title
Visual analog scale for pain
Description
Scale from 0.0 to 10.0.
Time Frame
48 hours after blood patch
Title
Visual analog scale for pain
Description
Scale from 0.0 to 10.0.
Time Frame
72 hours after blood patch
Title
Presence/absence of complications
Description
Presence / absence of the following complications: nerve paresthesia; nerve damage; accidental dural puncture; subcutaneous hematoma at the puncture site; meningitis; epidural abscess; localized infection at the puncture site; encephalopathy; cerebral venous thrombosis; subdural hematoma
Time Frame
During hospital stay (expected average of 7 days)
Title
In case of recurrence of headache following the 1st blood patch, the presence / absence of the following accompanying symptoms: nausea; vomiting; dizziness; tinnitus; diplopia; photophobia; low back pain.
Time Frame
During hospital stay (expected average of 7 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient was informed about the implementation of the study, its objectives, constraints and patient rights The patient has signed the informed consent The patient must be affiliated or beneficiary of a health insurance plan The patient is available for follow up concerning her hospital stay The patient has a post-dural puncture headache after a vaginal delivery. The diagnosis of post-puncture headache is retained on the basis of a frankly postural character for the headache, triggered or exacerbated by orthostatic position and relieved by recumbency. The patient has an indication for a blood patch Exclusion Criteria: The patient is participating in another interventional study, with the exception of the following studies: Papillo PMA (2013-A00538-37); DG-Postpartum (2013-A00277-38); ElastoMAP (2013-A01148-37); ElastoDéclench (2014-A00828-39); LXRs(2009-A00968-49); OASIS II (2013-A00773-42); GrossPath (2014-A01120-47). The patient is in an exclusion period determined by a previous study The patient is under guardianship, curatorship or under judicial protection The patient refuses to sign the consent It is not possible correctly inform the patient The patient is pregnant The patient has a contra-indication (or an incompatible combination therapy) for a necessary treatment in this study The patient was delivered by cesarean section
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Aya, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache

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