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

• ClinicalTrials.gov Identifier: NCT02149680
• Recruitment Status: Completed
• First Posted: May 29, 2014
• Last Update Posted: September 29, 2015
• Sponsor: Örebro University, Sweden
• Collaborator: 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

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

Condition

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 28, 2014): 60
• 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

Sex/Gender

• 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

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