Headache After Diagnostic Lumbar Puncture
NCT03960749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000
Last updated 2019-05-23
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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