Post-dural Puncture Headache - Needles and Biomarkers in CSF
Condition: Post-dural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional

Summary: 
      Post-dural puncture headache (PDPH) is the most common complication following lumbar puncture
      (LP). The frequency varies widely depending on a number of factors, among which patient
      characteristics, case ascertainment, gauge and type of needle used are of significant
      importance. In 2001, Strupp et al. showed that over 12 % of 115 patients who were subjected
      to diagnostic lumbar puncture with a 22 gg (0.7 mm) atraumatic needle suffered post-dural
      puncture headache, while over 24 % of 115 who were given a lumbar puncture with a 22 gg
      traumatic needle suffered a headache. This finding provided the basis for an American
      recommendation to use a 22 gg atraumatic needle for diagnostic lumbar puncture. A later study
      with 58 patients has shown an even greater difference (36 % versus 3 % post-dural puncture
      headache) when an atraumatic needle is used. Despite these findings, European Neurologist
      continue to hold on to the cutting needle. Here the investigators propose a prospective
      randomized study design with double masking; neither patient nor evaluator of PDPH aware of
      the needle design used, and with an active ascertainment of the occurrence of PDPH in
      accordance with updated headache classification guidelines. The investigators also intend to
      investigate whether specific neuroinflammatory substances and metabolites (different outcome
      variables) in the cerebrospinal fluid (CSF) will affect the explanatory variable.
    

Detailed description: 
      Subjects are patients scheduled for a diagnostic LP as part of their routine clinical
      management at the department of Neurology, Nordland Hospital in Bodø, Norway. Selection is
      based on the inclusion and exclusion criteria listed beneath, independent of the primary
      clinical indication for the procedure.

      Informed consenting patients will be randomised in two groups based on needle type. The
      traumatic group using Spinocan® (Quincke) 22Gx3.5" needle and atraumatic group using Pencan®
      (Sprotte) 22Gx3.5" needle. The randomisation process will be via an internet web-based
      application, provided by Norwegian university of science and Technology
      (http://www.ntnu.edu/dmf/akf/randomisering).

      Subjects will undergo standard lumbar puncture, all in lateral recumbent position, the needle
      inserted, preferentially in level L3-4, perpendicular or parallel to the dural fibers, and
      CSF will be collected in accordance with the study protocol. Information about the LP,
      eventual complications, CSF volumes tapped and standard CSF-findings are noted.

      Follow-up will be performed by investigators that are masked to the randomization. Patients
      will be interviewed over the telephone, alternatively in person if hospitalised, the first 1
      and 7th day after the LP.Subjects that do develop PDPH will be treated in-line with
      established and standardized protocols at the department of Neurology, Nordland Hospital
      Trust, Bodø. Given that PDPH has a natural history of spontaneous resolution within 1-12
      days, patients suffering from PDPH will be treated conservatively for the duration of the
      first 7 days after PDPH diagnosis. Conservative therapy, based on symptoms severity and
      patients' responsiveness, consist of the following: bed rest, caffeine, analgesics
      (paracetamol, NSAIDS), antiemetics and i.v. hydration. If the headache is severe and
      disabling and non-respondent after 7 days of conservative therapy, epidural blood patch will
      be administered. If a patient diagnosed with PDPH has a change in the pain character, or
      develops additional neurological manifestations, an urgent brain CT scan or MRI is indicated
      to exclude rarer potentially life-threatening intracranial complications.
    

Intervention name(s): Traumatic needle; Atraumatic needle
Intervention type(s): Device; Device
Intervention description(s): Lumbar puncture is performed with a traumatic needle; Lumbar puncture is performed with an atraumatic needle
Other intervention name(s): Spinocan® (Quincke) 22Gx3.5"; Pencan® (Sprotte) 22Gx3.5"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention