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Post-dural Puncture Headache - Needles and Biomarkers in CSF

This study is currently recruiting participants.
Verified May 2016 by Nordlandssykehuset HF
Sponsor:
ClinicalTrials.gov Identifier:
NCT02384031
First Posted: March 10, 2015
Last Update Posted: May 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Imperial College London
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Nordlandssykehuset HF
  Purpose
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.

Condition Intervention
Post-dural Puncture Headache Device: Traumatic needle Device: Atraumatic needle

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Quincke vs. Sprotte and Post-dural Puncture Headache - a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Nordlandssykehuset HF:

Primary Outcome Measures:
  • Post-dural puncture headache (PDPH) [ Time Frame: At day 7 post LP ]

Secondary Outcome Measures:
  • Levels of neuropeptides in CSF [ Time Frame: During lumbar puncture ]
  • Levels of metabolites in CSF [ Time Frame: During lumbar puncture ]
  • Levels of inflammatory mediators in CSF [ Time Frame: During lumbar puncture ]

Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traumatic group
Traumatic needle
Device: Traumatic needle
Lumbar puncture is performed with a traumatic needle
Other Name: Spinocan® (Quincke) 22Gx3.5"
Active Comparator: Atraumatic group
Atraumatic needle
Device: Atraumatic needle
Lumbar puncture is performed with an atraumatic needle
Other Name: Pencan® (Sprotte) 22Gx3.5"

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Patients at Department of Neurology, Nordland Hospital Trust in Bodø, scheduled for diagnostic LP

Exclusion Criteria:

  1. Dementia
  2. Non-compliance or coma
  3. Local skin infections over proposed puncture site
  4. Suspicion of raised intracranial pressure due to neurological or radiological findings
  5. Bleeding diathesis (thrombocytopenia <50 x 109/L) or ongoing anticoagulant therapy
  6. Major spinal column deformities
  7. Procedural complications whereby needle type or size change is a requisite
  8. Recent LP (< 7 days)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384031


Contacts
Contact: Francis Odeh, MD, PhD +47 75524000 Francis.Odeh@nordlandssykehuset.no
Contact: Karl Alstadhaug, MD, PhD +47 94781939 karl.bjornar.alstadhaug@nlsh.no

Locations
Norway
Departement of Neurology, NLSH HF Recruiting
Bodø, Norway, 8092
Contact: Francis Odeh, MD, PhD    +47 75534000    Francis.Odeh@nlsh.no   
Principal Investigator: Karl Alstadhaug, MD, PhD         
Principal Investigator: Francis Odeh, MD, PhD         
Sub-Investigator: Farid Baloch, MD         
Sub-Investigator: Diana Berg, MD         
Sub-Investigator: Ane Sjulstad, MD         
Sponsors and Collaborators
Nordlandssykehuset HF
Imperial College London
Norwegian University of Science and Technology
Investigators
Principal Investigator: Karl Alstadhaug, MD, PhD Nordlandssykehuset HF
Principal Investigator: Francis Odeh, MD, PhD Nordlandssykehuset HF
  More Information

Responsible Party: Nordlandssykehuset HF
ClinicalTrials.gov Identifier: NCT02384031     History of Changes
Other Study ID Numbers: 2011/1083/REK nord
First Submitted: February 27, 2015
First Posted: March 10, 2015
Last Update Posted: May 23, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases