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OpenTrials
Completed

NCT Number: NCT03960749

Headache After Diagnostic Lumbar Puncture

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

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Key information

Conditions

Post-Lumbar Puncture Headache Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-Dural Puncture Headache Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sprotte 25G needle, stylet reinserted

Device

Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal

Sprotte 25G needle, stylet not reinserted

Device

Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal

Sprotte 22G needle, stylet reinserted

Device

Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal

Sprotte 22G needle, stylet not reinserted

Device

Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal

Spinocan 25G needle, stylet reinserted

Device

Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal

Spinocan 25G needle, stylet not reinserted

Device

Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal

Primary outcomes

  1. Odds ratio for post-lumbar puncture headache (any)

    Time frame: Up to 14 days after LP

    Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).

Secondary outcomes

  1. Odds ratio for post-lumbar puncture headache (severe)

    Time frame: 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).

  2. Headache duration (days)

    Time frame: Until cessation, up to 14 days after LP

  3. Proportion using analgesia

    Time frame: During post-lumbar puncture headache, up to 14 days after LP

  4. Proportion on sick leave

    Time frame: During post-lumbar puncture headache, up to 14 days after LP

  5. Proportion with back pain

    Time frame: Up to 14 days after LP

  6. Proportion with radiating leg pain

    Time frame: Up to 14 days after LP

  7. Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model

    Time frame: 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.

Other outcomes

  1. Procedure duration (minutes)

    Time frame: 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).

  2. Proportion undergoing needle switch

    Time frame: During the lumbar puncture

    Technical difficulties may differ between needles and thus the proportion undergoing needle switch due to these difficulties may differ.

  3. Opening pressure (cm H2O)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jonatan Salzer

Other Gov

Collaborators

  • Umeå University

Registry information

Official study title

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

Acronym: HELPUmeå

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 23, 2019
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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