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

Not Applicable

Terminated

• Conditions: Post-Dural Puncture Headache
• Interventions: Other: Prone position for 1 hour after blood patch; Procedure: Blood patch

• Registration Number: NCT02427009
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-27
• Study Start: 2015-12
• Primary Completion: 2016-04-21
• Study Completion: 2016-04-23
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The study population	Prone position for 1 hour after blood patch	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
The study population	Blood patch	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

Primary Outcome Measures

Name	Time	Method
Headache recurrence: yes/no	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

Name	Time	Method
The number of blood patches required for each patient	Hospital discharge (expected average of 7 days)
Visual analog scale for pain	72 hours after blood patch	Scale from 0.0 to 10.0.
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.	During hospital stay (expected average of 7 days)
Presence/absence of complications	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

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France