Clinical trial NCT03960749: Headache After Diagnostic Lumbar Puncture
Official title: The Importance of Needle Size, Needle Design and Stylet Reinsertion to Prevent Post-lumbar Puncture Headache, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Lumbar Puncture Headache
Keywords: Lumbar puncture
Headache
Lead sponsor: Region Västerbotten
Sponsor class: OTHER_GOV
Collaborators: name: Umeå University
First posted: 2019-05-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel group. Randomization between three different lumbar puncture needles and between stylet reinsertion of not before needle withdrawal.
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Odds ratio for post-lumbar puncture headache (any)
timeFrame: Up to 14 days after LP
Secondary outcomes:
measure: Odds ratio for post-lumbar puncture headache (severe)
timeFrame: Up to 14 days after LP
measure: Headache duration (days)
timeFrame: Until cessation, up to 14 days after LP
measure: Proportion using analgesia
timeFrame: During post-lumbar puncture headache, up to 14 days after LP
measure: Proportion on sick leave
timeFrame: During post-lumbar puncture headache, up to 14 days after LP
measure: Proportion with back pain
timeFrame: Up to 14 days after LP
measure: Proportion with radiating leg pain
timeFrame: Up to 14 days after LP
measure: Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model
timeFrame: Up to 14 days after LP
Other outcomes:
measure: Procedure duration (minutes)
timeFrame: During the lumbar puncture
measure: Proportion undergoing needle switch
timeFrame: During the lumbar puncture
measure: Opening pressure (cm H2O)
timeFrame: During the lumbar puncture
Locations:
Study officials:
References:
citation: Evans RW, Armon C, Frohman EM, Goodin DS. Assessment: prevention of post-lumbar puncture headaches: report of the therapeutics and technology assessment subcommittee of the american academy of neurology. Neurology. 2000 Oct 10;55(7):909-14. doi: 10.1212/wnl.55.7.909. No abstract available.
citation: Hyllienmark L, Zachau AC. [Diagnostic lumbal puncture]. Lakartidningen. 2008 Oct 8-14;105(41):2844-9. No abstract available. Swedish.
citation: Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches [RETIRED]: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. doi: 10.1212/01.wnl.0000173034.96211.1b.
citation: Strupp M, Brandt T. Should one reinsert the stylet during lumbar puncture? N Engl J Med. 1997 Apr 17;336(16):1190. doi: 10.1056/NEJM199704173361616. No abstract available.
citation: Hammond ER, Wang Z, Bhulani N, McArthur JC, Levy M. Needle type and the risk of post-lumbar puncture headache in the outpatient neurology clinic. J Neurol Sci. 2011 Jul 15;306(1-2):24-8. doi: 10.1016/j.jns.2011.04.004. Epub 2011 May 5.
citation: Strupp M, Schueler O, Straube A, Von Stuckrad-Barre S, Brandt T. "Atraumatic" Sprotte needle reduces the incidence of post-lumbar puncture headaches. Neurology. 2001 Dec 26;57(12):2310-2. doi: 10.1212/wnl.57.12.2310.