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

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

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.

Study Overview

• Status: Terminated
• Conditions: Post-Dural Puncture Headache
• Intervention / Treatment: Other: Prone position for 1 hour after blood patch; Procedure: Blood patch

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours after first blood patch
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	48 hours after first blood patch
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	72 hours after first blood patch

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of blood patches required for each patient		Hospital discharge (expected average of 7 days)
Visual analog scale for pain	Scale from 0.0 to 10.0.	Baseline (day 0)
Visual analog scale for pain	Scale from 0.0 to 10.0.	24 hours after blood patch
Visual analog scale for pain	Scale from 0.0 to 10.0.	48 hours after blood patch
Visual analog scale for pain	Scale from 0.0 to 10.0.	72 hours after blood patch
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	During hospital stay (expected average of 7 days)
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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Guy Aya, MD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): April 21, 2016
• Study Completion (Actual): April 23, 2016

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 22, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: LOCAL/2015/GA-01; 2014-A01921-46 (Other Identifier: RCB number)