Headache After Diagnostic Lumbar Puncture

Post-Lumbar Puncture Headache Clinical Trial

— HELPUmeå  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03960749
• Other study ID #: HELP Umeå
• Status: Completed
• Phase: N/A
• Start date: May 28, 2013
• Est. completion date: October 11, 2018

Study information

• Verified date: May 2019
• Source: Västerbotten County Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 11, 2018
• Est. primary completion date: June 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Post-Lumbar Puncture Headache
• Wounds and Injuries

Intervention

Device:
• Sprotte 25G needle, stylet reinserted
Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal
• Sprotte 25G needle, stylet not reinserted
Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal
• Sprotte 22G needle, stylet reinserted
Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal
• Sprotte 22G needle, stylet not reinserted
Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal
• Spinocan 25G needle, stylet reinserted
Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal
• Spinocan 25G needle, stylet not reinserted
Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jonatan Salzer	Umeå University

References & Publications (6)

Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. — View 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. — View 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. — View Citation

Hyllienmark L, Zachau AC. [Diagnostic lumbal puncture]. Lakartidningen. 2008 Oct 8-14;105(41):2844-9. Swedish. — View Citation

Strupp M, Brandt T. Should one reinsert the stylet during lumbar puncture? N Engl J Med. 1997 Apr 17;336(16):1190. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedure duration (minutes)	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).	During the lumbar puncture
Other	Proportion undergoing needle switch	Technical difficulties may differ between needles and thus the proportion undergoing needle switch due to these difficulties may differ.	During the lumbar puncture
Other	Opening pressure (cm H2O)	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.	During the lumbar puncture
Primary	Odds ratio for post-lumbar puncture headache (any)	Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).	Up to 14 days after LP
Secondary	Odds ratio for post-lumbar puncture headache (severe)	Severe (preventing daily activities) post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).	Up to 14 days after LP
Secondary	Headache duration (days)		Until cessation, up to 14 days after LP
Secondary	Proportion using analgesia		During post-lumbar puncture headache, up to 14 days after LP
Secondary	Proportion on sick leave		During post-lumbar puncture headache, up to 14 days after LP
Secondary	Proportion with back pain		Up to 14 days after LP
Secondary	Proportion with radiating leg pain		Up to 14 days after LP
Secondary	Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model	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.	Up to 14 days after LP