Headache After Diagnostic Lumbar Puncture

NCT03960749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2019-05-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Umeå University

    collaborator OTHER
  • Jonatan Salzer

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-28
Primary Completion
2018-06-24
Completion
2018-10-11

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03960749 on ClinicalTrials.gov