NCT03960749

Headache After Diagnostic Lumbar Puncture

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Jonatan Salzer · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Conditions

• Post-Lumbar Puncture Headache

Interventions

Type	Name	Description
DEVICE	Sprotte 25G needle, stylet reinserted	Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal
DEVICE	Sprotte 25G needle, stylet not reinserted	Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal
DEVICE	Sprotte 22G needle, stylet reinserted	Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal
DEVICE	Sprotte 22G needle, stylet not reinserted	Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal
DEVICE	Spinocan 25G needle, stylet reinserted	Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal
DEVICE	Spinocan 25G needle, stylet not reinserted	Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal

Timeline

• Start date: 2013-05-28
• Primary completion: 2018-06-24
• Completion: 2018-10-11
• First posted: 2019-05-23
• Last updated: 2019-05-23