The objectives of this study are to investigate the effects of needle design, needle size and stylet reinsertion on the risk for headache after diagnostic LP (lumbar puncture, Post-LP headache). The following needles are used in the study: 1. Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer 2. Sprotte 22 G (0.7 mm) atraumatic needle with introducer 3. Spinocan 25 G (0.5 mm) cutting needle
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,000
Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal
Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal
Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal
Odds ratio for post-lumbar puncture headache (any)
Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
Time frame: Up to 14 days after LP
Odds ratio for post-lumbar puncture headache (severe)
Severe (preventing daily activities) post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
Time frame: Up to 14 days after LP
Headache duration (days)
Time frame: Until cessation, up to 14 days after LP
Proportion using analgesia
Time frame: During post-lumbar puncture headache, up to 14 days after LP
Proportion on sick leave
Time frame: During post-lumbar puncture headache, up to 14 days after LP
Proportion with back pain
Time frame: Up to 14 days after LP
Proportion with radiating leg pain
Time frame: Up to 14 days after LP
Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model
Interactions between important predictors of headache and needle allocation, assessed in multivariable logistic regression models with interaction terms which are the products of the two potentially interacting variables. Age and BMI will be treated as continuous variables, sex and needle allocation as categorical variables.
Time frame: Up to 14 days after LP
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Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal
Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal
Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal