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

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ClinicalTrials.gov 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

Tracking Information
First Submitted Date May 25, 2014
First Posted Date May 29, 2014
Last Update Posted Date September 29, 2015
Study Start Date January 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2014)
Audiometric changes [ Time Frame: 3 - 8 years after event ]
Changes in oto-acoustic emission and tone-audiometry
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 28, 2014)
  • Headache [ Time Frame: During the last month ]
    Has the patient been affected by persistent or positional headaches, their character and localization
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Long-term Effects of Accidental Dural Puncture in Patients Having Had an Epidural Blood Patch (LEAP)
Official Title Long-term Follow-up of Patients Having Had an Epidural Blood Patch Following Accidental Dural Puncture During Labour or Caesarean Section
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.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
  • Post-dural Puncture Headache
  • Post-dural Puncture Backache
Intervention Not Provided
Study Groups/Cohorts
  • 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).
Publications * Darvish B, Gupta A, Alahuhta S, Dahl V, Helbo-Hansen S, Thorsteinsson A, Irestedt L, Dahlgren G. Management of accidental dural puncture and post-dural puncture headache after labour: a Nordic survey. Acta Anaesthesiol Scand. 2011 Jan;55(1):46-53. doi: 10.1111/j.1399-6576.2010.02335.x. Epub 2010 Oct 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 28, 2014)
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sexes Eligible for Study: Female
Ages 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
Administrative Information
NCT Number NCT02149680
Other Study ID Numbers LEAP-2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Anil Gupta, Örebro University, Sweden
Original Responsible Party Same as current
Current Study Sponsor Örebro University, Sweden
Original Study Sponsor Same as current
Collaborators Karolinska Institutet
Investigators Not Provided
PRS Account Örebro University, Sweden
Verification Date September 2015