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 |
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Recruitment Status :
Completed
First Posted : May 29, 2014
Last Update Posted : September 29, 2015
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| Condition or disease |
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| Post-dural Puncture Headache Post-dural Puncture Backache |
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 |
| 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 |
| Group/Cohort |
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Experimental group
Patient who has had an epidural blood patch following accidental dura puncture during pregnancy
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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).
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- Audiometric changes [ Time Frame: 3 - 8 years after event ]Changes in oto-acoustic emission and tone-audiometry
- 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
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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 |
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
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 ClinicalTrials.gov identifier (NCT number): NCT02149680
| Sweden | |
| Karolinska Hospital | |
| Stockholm, Sweden | |
| University Hospital | |
| Örebro, Sweden | |
| Responsible Party: | Anil Gupta, Associate Professor, Örebro University, Sweden |
| ClinicalTrials.gov 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 |
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Post-dural puncture headache epidural blood patch labour analgesia epidural analgesia |
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Post-Dural Puncture Headache Headache Wounds and Injuries Pain Neurologic Manifestations |
Headache Disorders, Secondary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |