Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch.
Condition: Post-Dural Puncture Headache; Chronic Headache
MeSH terms: Post-Dural Puncture Headache; Headache Disorders; Headache; Wounds and Injuries
Study type: Observational

Summary: 
      The investigators plan to evaluate long-term consequences of unintentional dural puncture in
      women who had this complication during labor epidural insertion at Mount Sinai Hospital. A
      dural puncture is the perforation of the dura mater (one of the layers protecting the brain
      and the spinal cord) by the needle that is used to find and place a catheter in the epidural
      space. A puncture will cause a leakage of cerebrospinal fluid through the dura that results
      in an acute and usually self-limited headache in half of patients who have this complication.
      The usual treatment for this complication is conservative with the use of oral medications
      like acetaminophen, anti-inflammatory and narcotics. In the severely symptomatic patient, the
      injection of blood in the epidural space is a more invasive approach performed to "patch" the
      hole that was created in the dura (epidural blood patch). The objective is to determine
      whether or not there is a risk of developing long-term effects from the unintentional dural
      puncture and its treatment by epidural blood patch by comparing women who had a dural
      puncture during their labour epidural insertion with or without an epidural blood patch with
      women who received an epidural but did not have a dural puncture during the same period of
      time.

      The hypothesis is that women who had unintentional dural punctures during epidural insertion
      will develop long-term effects such as chronic headache, chronic backache, chronic auditory
      or visual disturbances and chronic disability more frequently than women who received an
      epidural but did not sustain a dural puncture. The investigators also hypothesize that the
      use of epidural blood patch may change the course of these complications.
    

Detailed description: 
      The investigators will study women who have sustained an unintentional dural puncture at
      least one year prior to the start date of the study, and the investigators will study cases
      occurring during a period of 5 years. These women will be matched by type of procedure (labor
      epidural), month of delivery and age with women who have received an epidural but did not
      sustain an unintentional dural puncture. The group of women who sustained dural punctures
      will be further divided into two groups, whether they have received epidural blood patch or
      not, to study the influence of the epidural blood patch on the outcomes. Women will have
      their anesthetic records reviewed to collect data on the anesthetic technique, presence of a
      dural puncture and treatment if applicable. All patients who qualify will be contacted and
      invited to take part in this study. Those consenting to the study will be interviewed by
      phone or answer the survey electronically. During the interview, they will answer questions
      derived from validated questionnaires for the majority of our outcomes of interest. In the
      few outcomes where a validated questionnaire does not exist, the investigators will search
      for our endpoint with dichotomic (yes/no) questions. The investigators will then compare the
      data gathered in the three different groups to validate or invalidate our hypothesis.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Participants from all 3 groups will be interviewed
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with labour epidurals inserted at Mount Sinai hospital from January 2015 to
        December 2019 with well-documented recognized unintentional dural punctures will be invited
        to participate.

        Control patients who received labor epidural matched by month of delivery, age, and body
        mass index (grouped as either below or above a body mass index of 40) will also be
        approached for enrollment.
      
Keywords: post-dural puncture headache; labour epidural; chronic headache; chronic backache