Trial record 5 of 37 for:    LEAP

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Örebro University, Sweden
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden
ClinicalTrials.gov Identifier:
NCT02149680
First received: May 25, 2014
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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
Post-dural Puncture Headache
Post-dural Puncture Backache

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Örebro University, Sweden:

Primary Outcome Measures:
  • Audiometric changes [ Time Frame: 3 - 8 years after event ] [ Designated as safety issue: No ]
    Changes in oto-acoustic emission and tone-audiometry


Secondary Outcome Measures:
  • Headache [ Time Frame: During the last month ] [ Designated as safety issue: No ]
    Has the patient been affected by persistent or positional headaches, their character and localization

  • Backache [ Time Frame: Last 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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).

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02149680

Locations
Sweden
Karolinska Hospital Recruiting
Stockholm, Sweden
Contact: Bijan Darvish, MD    08-517 700 00    bijan.darvish@ki.se   
Contact: Lars Irestedt, PhD    08-517 700 00    lars.irestedt@ki.se   
Principal Investigator: Bijan Darvish, MD         
University Hospital Recruiting
Örebro, Sweden
Contact: Anil Gupta, PhD    019-6021000 ext 20256    anil.gupta@orebroll.se   
Contact: Titti Thoren, PhD    019-6021000    titti.thoren@orebroll.se   
Principal Investigator: Anil Gupta, PhD         
Sponsors and Collaborators
Örebro University, Sweden
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Anil Gupta, Associate Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT02149680     History of Changes
Other Study ID Numbers: LEAP-2013
Study First Received: May 25, 2014
Last Updated: May 28, 2014
Health Authority: Örebro University Sweden:

Keywords provided by Örebro University, Sweden:
Post-dural puncture headache
epidural blood patch
labour analgesia
epidural analgesia

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014