Chronic Headache and Chronic Backache Following Unintentional Dural Puncture at Delivery Room.
Condition: Parturient Who Underwent Epidural Anesthesia During Which an Unintentional Dural Punctur Occurred; Parturient Who Develop a Postdural Puncture Headache; Parturient Who Gave Informed Consent to Participation in the Study
MeSH terms: Headache Disorders; Post-Dural Puncture Headache; Headache; Back Pain; Wounds and Injuries
Study type: Observational

Summary: 
      he study is a telephone questionnaire. The study will include 400 women, 100 in each group.

      OBJECTIVE: To investigate the prevalence of chronic and chronic back pain following PDPH
      accidental dural puncture during epidyral analgesia for delivery.

        1. Parturients who gave birth to a normal birth and did not receive epidural anesthesia.

        2. Parturients who gave birth to a normal birth with epidural anesthesia without an
           unintentional dural puncture.

        3. Parturients who gave birth to a normal birth with epidural anesthesia and had an
           unintentional dural puncture, these women were treated conservatively.

        4. Parturients who had a normal birth with epidural anesthesia and had an unintentional
           dural puncture and were treated with a blood patch following PDPH.
    

Detailed description: 
      Epidural anesthesia for pain relief during childbirth is performed in about 70% of the
      parturients in Shaare Zedek Medical Center. The most common complication of epidural
      analgesia is an unintentional dural puncture occurring in 0.4% -6% of births. Puncture causes
      acute headache in 70% -80% of cases. The standard treatment is the first stage of
      conservative treatment of painkillers and caffeine and in the absence of improvement of
      perform epidural blood patch 24-48 hours after the dural puncture was performed.

      There is no widespread support for the literature that a dural puncture with a large diameter
      needle is a risk factor for the development of chronic headache. For this purpose, we are
      interested in conducting a study to examine the prevalence of chronic headache and back pain
      in parturients who underwent epidural anesthesia with a dural puncture to confront
      parturients who underwent epidural anesthesia without puncturing the dura membrane.

      We know that in the years 2017-208 there were about 100 women in the hospital who had a blood
      patch and a similar number of women who had PDPH and were treated conservatively. From the
      medical records, we will randomize another 200 mothers, of which 100 were born naturally
      without epidural anesthesia and another 100 who gave birth to a normal birth with epidural
      anesthesia without dural puncture.

      The study will be conducted using a telephone questionnaire. The telephone questionnaire will
      be taken at least six months after the epidural anesthesia check if the symptoms are chronic
      in nature.

      Telephone questionnaire carried out four groups of mothers:

        1. Parturients who gave birth to a normal birth and did not receive epidural anesthesia.

        2. Parturients who gave birth to a normal birth with epidural anesthesia without an
           unintentional dural puncture.

        3. Parturients who gave birth to a normal birth with epidural anesthesia and had an
           unintentional dural puncture, these women were treated conservatively.

        4. Parturients who had a normal birth with epidural anesthesia and had an unintentional
           dural puncture and were treated with a blood patch following PDPH.

      The questionnaire will be performed after receiving informed consent from the patient. Each
      group will have 100 women.

      The questionnaire (attached as an appendix) will examine the prevalence of chronic headache
      and chronic back pain in these women. Our hypothesis is that in women with PDPH the incidence
      of chronic headache will be higher.

      The statistical comparison between the groups will examine demographic characteristics and
      characteristics related to frequency of pain, intensity, restriction of daily activity and
      ways to relieve pain.

      Comparisons between the groups for continuous variables will be done with the student t-test
      and data are presented as mean (standard deviation (SD)), for nonparametric tests with
      Mann-Whitney test and data are presented as median (interquartile range) ) [range] and for
      categorical values with Chi-square test and data are presented as number (percentage). A
      p-values <0.01 will be considered significant due to multiple comparisons. A multivariable
      regression analysis will be performed to evaluate factors (PDPH, epidural blood patch (EBP),
      chronic headache, chronic backache) associated with PPD.
    

Intervention name(s): Epidural Blood patch.
Intervention type(s): Other
Intervention description(s): An epidural blood patch is a surgical procedure that uses autologous blood in order to close one or many holes in the dura mater of the spinal cord, usually as a result of a previous lumbar puncture. A small amount of the patient's blood is injected into the epidural space near the site of the original puncture; the resulting blood clot then "patches" the meningeal leak. An epidural needle is inserted into the epidural space at the site of the cerebrospinal fluid leak and blood is injected. The clotting factors of the blood close the hole in the dura.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women who gave birth at Shaare Zedek Medical Center are a tertiary hospital with more than
        16,000 births a year. Fifty-five percent of women give birth with epidural anesthesia.
      
Keywords: PDPH - Post Dural Puncture Headache; chronic headache; chronic backache