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

NCT02427009 | Terminated

• 2 other identifiers: LOCAL/2015/GA-012014-A01921-46
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• The number of blood patches required for each patient

  Hospital discharge (expected average of 7 days)

• Visual analog scale for pain

  Baseline (day 0)

• Visual analog scale for pain

  24 hours after blood patch

• Visual analog scale for pain

  48 hours after blood patch

• Visual analog scale for pain

  72 hours after blood patch

Study Arms (1)

The study population

EXPERIMENTAL

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; Procedure: Blood patch

Interventions

Prone position for 1 hour after blood patch 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.

The study population

Blood patch 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.

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Prone Position; Blood Patch, Epidural

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Biological Therapy; Therapeutics; Injections, Epidural; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy

Study Officials

• Guy Aya, MD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 27, 2015
• Study Start: December 1, 2015
• Primary Completion: April 21, 2016
• Study Completion: April 23, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

FR (1)