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Long-term Effects of Accidental Dural Puncture in Patients Having Had an Epidural Blood Patch (LEAP) (LEAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02149680
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : September 29, 2015
Karolinska Institutet
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden

Brief Summary:
Accidental dural puncture (ADP) during placement of an epidural catheter for anesthesia and analgesia is a well known complication. Previous studies have found audiometric deterioration following ADP. Epidural blood patch (EBP) is a common method for treating postural headache in patients with accidental dural puncture. In most cases, one-two patches are needed for successful management. Long-term effects of EBP on the incidence of backache, headache and early audiometric deterioration are few or non-existant. The present study aims to determine the long-term sequelae of EDP in parturients who had ADP and were treated with an EBP during the years 2005 - 2011.

Condition or disease
Post-dural Puncture Headache Post-dural Puncture Backache

Detailed Description:

A major risk with epidural analgesia (EDA) is accidental dural puncture (ADP). ADP occurs in approximately 1% of all pregnant women receiving EDA in connection with childbirth. Postdural puncture headache (PDPH) is the most common complication after ADP and affects approximately 86% of all mothers with ADP. Headache after ADP may be severe and sometimes affects the interaction between the newborn baby and the mother. The headaches are orthostatic which makes the patient bedridden, and are associated with symptoms such as nausea, vomiting, tinnitus and hearing changes. The symptoms are thought to represent leakage of cerebrospinal fluid (CSF), which in turn leads to reduced CSF volume and intracranial hypotension. These volume changes lead to traction of pain-sensitive intracranial structures. There are no studies in the literature that have either confirmed or visualized CSF leakage after ADP. The diagnosis of PDPH is solely based on clinical examination. There are over 50 different treatment options for PDPH. These treatments can be divided into conservative or invasive. Among others, the conservative treatment options include bed rest, caffeine and various pain medications. Several studies have shown the absence of a definite and curative effect of these treatment options. The most widely used invasive method for management of PDPH is epidural blood patch (EBP). EBP was first introduced in the 60's by applying three ml of the patients' own blood epidurally. Over the years, this volume has increased to at least 15-20 ml on the basis of case reports and studies with small number of participants and without any definite scientific evidence. However, EBP should not be applied sooner than 24 hours after the onset of accidental dura puncture, as the risk of failure is higher. Further studies are required in the literature to confirm the efficacy of EBP.

Additionally, the long term effects of EBP remain either unknown or vaguely understood. Are we treating an acute symptom with an invasive method, not knowing the long term sequelae? Since audiometric changes are known to result following ADP, can these changes persist over a long period of time? Therefore, we are interested in assessing the long term effects of EBP on backache, headache and audiometric changes in parturients who delivered during the years 2005 - 2011.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Long-term Follow-up of Patients Having Had an Epidural Blood Patch Following Accidental Dural Puncture During Labour or Caesarean Section
Study Start Date : January 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Experimental group
Patient who has had an epidural blood patch following accidental dura puncture during pregnancy
Control Group
Women in the same group, equal numbers of those with or without epidurals, without accidental dural puncture, similar parity would constitute the control group. They would be chose at random, 10 times the number in the experimental group (n = 600).

Primary Outcome Measures :
  1. Audiometric changes [ Time Frame: 3 - 8 years after event ]
    Changes in oto-acoustic emission and tone-audiometry

Secondary Outcome Measures :
  1. Headache [ Time Frame: During the last month ]
    Has the patient been affected by persistent or positional headaches, their character and localization

  2. Backache [ Time Frame: Last 1 year ]
    Has the patient had problems with persistent backache that either prevents her from working full time, if there is any radiation of pain, its character and localization

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women who had delivered during the years 2005 - 2011. Experimental group: 60 patients who had an accidental dura puncture during labour or caesarean section and developed post-dura puncture headache and required an epidural blood patch would constitute the experimental group Contro group: 600 patients, identical to the above except that they had no dura puncture and therefore no post-dural puncture headache

Inclusion Criteria:

  • Women in the age group 20-45 years
  • Delivered during the years 2005-2011
  • Region of Örebro and Stockholm, Sweden

Exclusion Criteria:

  • Language difficulty
  • Mental inadequacy
  • Chronic backache or headache
  • Pre-eclampsia during pregnancy
  • Previous accidental dural puncture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02149680

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Karolinska Hospital
Stockholm, Sweden
University Hospital
Örebro, Sweden
Sponsors and Collaborators
Örebro University, Sweden
Karolinska Institutet
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Responsible Party: Anil Gupta, Associate Professor, Örebro University, Sweden Identifier: NCT02149680    
Other Study ID Numbers: LEAP-2013
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015
Keywords provided by Anil Gupta, Örebro University, Sweden:
Post-dural puncture headache
epidural blood patch
labour analgesia
epidural analgesia
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Wounds and Injuries
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases