Post-Lumbar Puncture Headache
Conditions
Keywords
Lumbar puncture, Headache
Brief summary
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
Interventions
DEVICESprotte 25G needle, stylet reinserted
Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal
DEVICESprotte 25G needle, stylet not reinserted
Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal
DEVICESprotte 22G needle, stylet reinserted
Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal
DEVICESprotte 22G needle, stylet not reinserted
Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal
DEVICESpinocan 25G needle, stylet reinserted
Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal
DEVICESpinocan 25G needle, stylet not reinserted
Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal
Sponsors
Umeå University
Jonatan Salzer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participants are not informed about the allocated needle. The follow-up telephone calls (outcome assessment) are made by an assistant nurse who is unaware of randomization allocation.
Intervention model description
Randomized, parallel group. Randomization between three different lumbar puncture needles and between stylet reinsertion of not before needle withdrawal.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Odds ratio for post-lumbar puncture headache (any) | Up to 14 days after LP | Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion using analgesia | 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 | Up to 14 days after LP | 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. |
| Odds ratio for post-lumbar puncture headache (severe) | Up to 14 days after LP | Severe (preventing daily activities) post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3). |
| Headache duration (days) | Until cessation, up to 14 days after LP | — |
| Proportion on sick leave | During post-lumbar puncture headache, up to 14 days after LP | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Opening pressure (cm H2O) | During the lumbar puncture | Opening pressure measured immediately after cerebrospinal fluid (CSF) contact using a thin tube attached to a paper ruler, using the skin entry hole as reference point. This is only performed in the recumbent position. |
| Procedure duration (minutes) | During the lumbar puncture | Procedure duration from start of procedure (defined as when the operator starts palpating the iliac crest) until procedure cessation (defined as when the needle is withdrawn from the participant). |
| Proportion undergoing needle switch | During the lumbar puncture | Technical difficulties may differ between needles and thus the proportion undergoing needle switch due to these difficulties may differ. |
Outcome results
None listed