Headache After Diagnostic Lumbar Puncture

Not Applicable

Completed

• Conditions: Post-Lumbar Puncture Headache
• Interventions: Device: Sprotte 22G needle, stylet not reinserted; Device: Sprotte 25G needle, stylet reinserted; Device: Sprotte 25G needle, stylet not reinserted; Device: Spinocan 25G needle, stylet reinserted; Device: Spinocan 25G needle, stylet not reinserted; Device: Sprotte 22G needle, stylet reinserted

• Registration Number: NCT03960749
• Lead Sponsor: Jonatan Salzer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-28
• Primary Completion: 2018-06-24
• Study Completion: 2018-10-11
• Status Verified: 2019-05
• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-20
• Last Update Submitted: 2019-05-20
• Study First Posted: 2019-05-23
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sprotte 22G needle, stylet not reinserted	Sprotte 22G needle, stylet not reinserted	-
Sprotte 25G needle, stylet reinserted	Sprotte 25G needle, stylet reinserted	-
Sprotte 25G needle, stylet not reinserted	Sprotte 25G needle, stylet not reinserted	-
Spinocan 25G needle, stylet reinserted	Spinocan 25G needle, stylet reinserted	-
Spinocan 25G needle, stylet not reinserted	Spinocan 25G needle, stylet not reinserted	-
Sprotte 22G needle, stylet reinserted	Sprotte 22G needle, stylet reinserted	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 using analgesia	During post-lumbar puncture headache, up to 14 days after LP
Proportion with back pain	Up to 14 days after LP
Proportion on sick leave	During post-lumbar puncture headache, 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.