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

NCT ID: NCT02427009

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-04-23

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.

Conditions

Post-Dural Puncture Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Prone position for 1 hour after blood patch

Intervention Type: OTHER

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.

Blood patch

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy Aya, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2014-A01921-46

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2015/GA-01

Identifier Type: -

Identifier Source: org_study_id