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

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Post-Dural Puncture Headache

Treatments: Other: Prone position for 1 hour after blood patch; Procedure: Blood patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02427009

2014-A01921-46 (Other Identifier)

LOCAL/2015/GA-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

The study population

Experimental group

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

Treatment:

Procedure: Blood patch

Other: Prone position for 1 hour after blood patch