Long Term Outcomes After Accidental Dural Puncture ADP Study
Condition: Post-Dural Puncture Headache; Chronic Headache; Chronic Low Back Pain
MeSH terms: Post-Dural Puncture Headache; Headache Disorders; Back Pain; Low Back Pain; Headache
Study type: Observational

Summary: 
      Post Dural Puncture Headache (PDPH) causes significant short-term disability, prevents
      mobilisation, affects childcare activities and results in prolonged hospital stay. Initial
      treatment involves painkillers and if patient fails to respond, an Epidural Blood Patch
      (EBP). EBP involves taking patient's blood and injecting into the epidural space. It is
      generally agreed that PDPH is a self-limiting condition and resolves in two weeks. However
      there is emerging evidence that patients with PDPH could be at an increased risk of
      developing longstanding (chronic) headaches. Retrospective case studies show that between 28
      - 34% of patients who developed PDPH had longstanding headaches at 18 months after the
      insertion of the epidural. There is also recent evidence of new onset low back pain
      developing in patients who have received an epidural blood patch that was performed to treat
      PDPH. Nearly two thirds of patients from a hospital in UK had new onset low back pain after
      they had received epidural blood patch treatment. Presently, there is no prospective clinical
      study evaluating the development of longstanding headaches and new onset low back pain after
      the development of PDPH. Aim of the present study is to evaluate the incidence of
      longstanding headache after accidental dural (ADP) puncture and the incidence of new onset
      low back pain after epidural blood patch treatment.
    

Detailed description: 
      Headache can be a complication after insertion of an epidural needle for pain relief during
      labour. The headache is called Post Dural Puncture Headache (PDPH). PDPH causes significant
      short-term disability, prevents mobilisation, affects childcare activities and results in
      prolonged hospital stay. Initial treatment involves painkillers and if patient fails to
      respond, an Epidural Blood Patch (EBP). EBP involves taking patient's blood and injecting
      into the epidural space. It is generally agreed that PDPH is a self-limiting condition and
      resolves in two weeks. However there is emerging evidence that patients with PDPH could be at
      an increased risk of developing longstanding (chronic) headaches. Retrospective case studies
      show that between 28 - 34% of patients who developed PDPH had longstanding headaches at 18
      months after the insertion of the epidural. There is also recent evidence of new onset low
      back pain developing in patients who have received an epidural blood patch that was performed
      to treat PDPH. Nearly two thirds of patients from a hospital in UK had new onset low back
      pain after they had received epidural blood patch treatment. Presently, there is no
      prospective clinical study evaluating the development of longstanding headaches and new onset
      low back pain after the development of PDPH.

      Aim of the present study is to evaluate the incidence of longstanding headache after
      accidental dural (ADP) puncture and the incidence of new onset low back pain after epidural
      blood patch treatment.

      Methods: The proposed study is a prospective, cohort study that will be conducted at six
      centres (Leicester, Derby, Bradford, Colchester, Bedford and Cambridge) over 36 months. Index
      participants who suffer ADP will be matched with control participants who have received an
      uneventful epidural insertion. The index and control participants will be matched for age,
      body weight, parity and the type of delivery. Mothers who have longstanding headache or low
      back pain will be excluded form the study. After providing written consent, the participants
      will be provided with a questionnaire pack containing three sets of two questionnaires to be
      completed at 6, 12 and 18 months after developing the headache as well as stamped envelopes
      to return the questionnaires to the research team. A research team member will perform
      telephone follow up 6, 12 and 18 months to encourage completion of the questionnaires.
      Participation in the study will end at 18 months after completion of the study
      questionnaires.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Obstetric