Headache After Diagnostic Lumbar Puncture

Study Overview
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Brief Summary
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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: Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer Sprotte 22 G (0.7 mm) atraumatic needle with introducer Spinocan 25 G (0.5 mm) cutting needle

Official Title
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The Importance of Needle Size, Needle Design and Stylet Reinsertion to Prevent Post-lumbar Puncture Headache, a Randomized Controlled Trial

Conditions
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Post-Lumbar Puncture Headache

Intervention / Treatment
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* Device: Sprotte 25G needle, stylet reinserted
* Device: Sprotte 25G needle, stylet not reinserted
* Device: Sprotte 22G needle, stylet reinserted
* Device: Sprotte 22G needle, stylet not reinserted
* Device: Spinocan 25G needle, stylet reinserted
* Device: Spinocan 25G needle, stylet not reinserted


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects undergoing diagnostic LP during their neurological work-up at Umeå University Hospital, Sweden, from 28 May 2013 until the study is fully recruited and; Willing to participate and Providing informed consent Exclusion Criteria: -Subjects unable to participate in the study follow-up

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, parallel group. Randomization between three different lumbar puncture needles and between stylet reinsertion of not before needle withdrawal.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sprotte 25G needle, stylet reinserted<br> | Device: Sprotte 25G needle, stylet reinserted<br>* Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal<br>|
| Experimental: Sprotte 25G needle, stylet not reinserted<br> | Device: Sprotte 25G needle, stylet not reinserted<br>* Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal<br>|
| Experimental: Sprotte 22G needle, stylet reinserted<br> | Device: Sprotte 22G needle, stylet reinserted<br>* Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal<br>|
| Experimental: Sprotte 22G needle, stylet not reinserted<br> | Device: Sprotte 22G needle, stylet not reinserted<br>* Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal<br>|
| Experimental: Spinocan 25G needle, stylet reinserted<br> | Device: Spinocan 25G needle, stylet reinserted<br>* Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal<br>|
| Experimental: Spinocan 25G needle, stylet not reinserted<br> | Device: Spinocan 25G needle, stylet not reinserted<br>* Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to 14 days after LP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to 14 days after LP | 
| Headache duration (days) |  | Until cessation, up to 14 days after LP | 
| Proportion using analgesia |  | During post-lumbar puncture headache, up to 14 days after LP | 
| Proportion on sick leave |  | During post-lumbar puncture headache, up to 14 days after LP | 
| Proportion with back pain |  | Up to 14 days after LP | 
| Proportion with radiating leg pain |  | 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. | Up to 14 days after LP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar puncture, Headache