Post-dural Puncture Headache - Needles and Biomarkers in CSF
Primary Purpose
Post-dural Puncture Headache
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Traumatic needle
Atraumatic needle
Sponsored by
About this trial
This is an interventional prevention trial for Post-dural Puncture Headache
Eligibility Criteria
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)
Sites / Locations
- Departement of Neurology, NLSH HF
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Traumatic group
Atraumatic group
Arm Description
Traumatic needle
Atraumatic needle
Outcomes
Primary Outcome Measures
Post-dural puncture headache (PDPH)
Secondary Outcome Measures
Levels of neuropeptides in CSF
Levels of metabolites in CSF
Levels of inflammatory mediators in CSF
Full Information
NCT ID
NCT02384031
First Posted
February 27, 2015
Last Updated
April 5, 2019
Sponsor
Nordlandssykehuset HF
Collaborators
Imperial College London, Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02384031
Brief Title
Post-dural Puncture Headache - Needles and Biomarkers in CSF
Official Title
Quincke vs. Sprotte and Post-dural Puncture Headache - a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordlandssykehuset HF
Collaborators
Imperial College London, Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-dural Puncture Headache
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traumatic group
Arm Type
Active Comparator
Arm Description
Traumatic needle
Arm Title
Atraumatic group
Arm Type
Active Comparator
Arm Description
Atraumatic needle
Intervention Type
Device
Intervention Name(s)
Traumatic needle
Other Intervention Name(s)
Spinocan® (Quincke) 22Gx3.5"
Intervention Description
Lumbar puncture is performed with a traumatic needle
Intervention Type
Device
Intervention Name(s)
Atraumatic needle
Other Intervention Name(s)
Pencan® (Sprotte) 22Gx3.5"
Intervention Description
Lumbar puncture is performed with an atraumatic needle
Primary Outcome Measure Information:
Title
Post-dural puncture headache (PDPH)
Time Frame
At day 7 post LP
Secondary Outcome Measure Information:
Title
Levels of neuropeptides in CSF
Time Frame
During lumbar puncture
Title
Levels of metabolites in CSF
Time Frame
During lumbar puncture
Title
Levels of inflammatory mediators in CSF
Time Frame
During lumbar puncture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Alstadhaug, MD, PhD
Organizational Affiliation
Nordlandssykehuset HF
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis Odeh, MD, PhD
Organizational Affiliation
Nordlandssykehuset HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Neurology, NLSH HF
City
Bodø
ZIP/Postal Code
8092
Country
Norway
12. IPD Sharing Statement
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Post-dural Puncture Headache - Needles and Biomarkers in CSF
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