Post-dural Puncture Headache - Needles and Biomarkers in CSF
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|ClinicalTrials.gov Identifier: NCT02384031|
Recruitment Status : Recruiting
First Posted : March 10, 2015
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Post-dural Puncture Headache||Device: Traumatic needle Device: Atraumatic needle||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Quincke vs. Sprotte and Post-dural Puncture Headache - a Randomised Controlled Trial|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||August 2019|
Active Comparator: Traumatic group
Device: Traumatic needle
Lumbar puncture is performed with a traumatic needle
Other Name: Spinocan® (Quincke) 22Gx3.5"
Active Comparator: Atraumatic group
Device: Atraumatic needle
Lumbar puncture is performed with an atraumatic needle
Other Name: Pencan® (Sprotte) 22Gx3.5"
- Post-dural puncture headache (PDPH) [ Time Frame: At day 7 post LP ]
- 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 ]
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
|Contact: Francis Odeh, MD, PhD||+47 75524000||Francis.Odeh@nordlandssykehuset.no|
|Contact: Karl Alstadhaug, MD, PhD||+47 firstname.lastname@example.org|
|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|
|Principal Investigator:||Karl Alstadhaug, MD, PhD||Nordlandssykehuset HF|
|Principal Investigator:||Francis Odeh, MD, PhD||Nordlandssykehuset HF|