- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02384031
Post-dural Puncture Headache - Needles and Biomarkers in CSF
Quincke vs. Sprotte and Post-dural Puncture Headache - a Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bodø, Norway, 8092
- Departement of Neurology, NLSH HF
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Patients at Department of Neurology, Nordland Hospital Trust in Bodø, scheduled for diagnostic LP
Exclusion Criteria:
- Dementia
- Non-compliance or coma
- Local skin infections over proposed puncture site
- Suspicion of raised intracranial pressure due to neurological or radiological findings
- Bleeding diathesis (thrombocytopenia <50 x 109/L) or ongoing anticoagulant therapy
- Major spinal column deformities
- Procedural complications whereby needle type or size change is a requisite
- Recent LP (< 7 days)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Traumatic group
Traumatic needle
|
Lumbar puncture is performed with a traumatic needle
Other Names:
|
Active Comparator: Atraumatic group
Atraumatic needle
|
Lumbar puncture is performed with an atraumatic needle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Post-dural puncture headache (PDPH)
Time Frame: At day 7 post LP
|
At day 7 post LP
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Levels of neuropeptides in CSF
Time Frame: During lumbar puncture
|
During lumbar puncture
|
Levels of metabolites in CSF
Time Frame: During lumbar puncture
|
During lumbar puncture
|
Levels of inflammatory mediators in CSF
Time Frame: During lumbar puncture
|
During lumbar puncture
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karl Alstadhaug, MD, PhD, Nordlandssykehuset HF
- Principal Investigator: Francis Odeh, MD, PhD, Nordlandssykehuset HF
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/1083/REK nord
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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