Long Term Outcomes After Accidental Dural Puncture ADP Study
Long Term Outcomes After Accidental Dural Puncture ADP Study
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.
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.
Inclusion Criteria:

 -  Index: Participants aged over 18 years who have sustained accidental dural puncture
 with 16-gauge Tuohy needle

 -  Control: Participants aged over 18 years who have received uneventful epidural
 insertion with 16-gauge Tuohy needle

 Exclusion Criteria:

 -  Lack of consent including from those participants who lack mental capacity to give
 informed consent

 -  Pre-existing chronic headache (the patients suffer from 15 or more headache days every
 month)

 -  Pre-existing chronic low back pain (the patients suffer from 7 or more low back pain
 days every month)