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

Post-Dural Puncture Headache Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02427009
• Other study ID #: LOCAL/2015/GA-01
• Secondary ID: 2014-A01921-46
• Status: Terminated
• Phase: N/A
• First received: April 20, 2015
• Last updated: January 30, 2017
• Start date: December 2015
• Est. completion date: April 23, 2016

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 23, 2016
• Est. primary completion date: April 21, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	The number of blood patches required for each patient		Hospital discharge (expected average of 7 days)
Secondary	Visual analog scale for pain	Scale from 0.0 to 10.0.	Baseline (day 0)
Secondary	Visual analog scale for pain	Scale from 0.0 to 10.0.	24 hours after blood patch
Secondary	Visual analog scale for pain	Scale from 0.0 to 10.0.	48 hours after blood patch
Secondary	Visual analog scale for pain	Scale from 0.0 to 10.0.	72 hours after blood patch
Secondary	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)
Secondary	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)