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

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ClinicalTrials.gov Identifier: NCT02427009
Recruitment Status : Terminated (no inclusion)
First Posted : April 27, 2015
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment Phase
Post-Dural Puncture Headache Other: Prone position for 1 hour after blood patch Procedure: Blood patch Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache
Study Start Date : December 2015
Actual Primary Completion Date : April 21, 2016
Actual Study Completion Date : April 23, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: The study population

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

Other: Prone position for 1 hour after blood patch
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.

Procedure: Blood patch
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 Measures :
  1. Headache recurrence: yes/no [ Time Frame: 24 hours after first blood patch ]
    Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby

  2. Headache recurrence: yes/no [ Time Frame: 48 hours after first blood patch ]
    Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby

  3. Headache recurrence: yes/no [ Time Frame: 72 hours after first blood patch ]
    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 :
  1. The number of blood patches required for each patient [ Time Frame: Hospital discharge (expected average of 7 days) ]
  2. Visual analog scale for pain [ Time Frame: Baseline (day 0) ]
    Scale from 0.0 to 10.0.

  3. Visual analog scale for pain [ Time Frame: 24 hours after blood patch ]
    Scale from 0.0 to 10.0.

  4. Visual analog scale for pain [ Time Frame: 48 hours after blood patch ]
    Scale from 0.0 to 10.0.

  5. Visual analog scale for pain [ Time Frame: 72 hours after blood patch ]
    Scale from 0.0 to 10.0.

  6. Presence/absence of complications [ Time Frame: During hospital stay (expected average of 7 days) ]
    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

  7. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427009


Locations
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France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: Guy Aya, MD Centre Hospitalier Universitaire de Nîmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02427009    
Other Study ID Numbers: LOCAL/2015/GA-01
2014-A01921-46 ( Other Identifier: RCB number )
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases