Headache After Diagnostic Lumbar Puncture

NCT03960749 | Completed

• 1 other identifier: HELP Umeå
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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. 1.Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer
2. 2.Sprotte 22 G (0.7 mm) atraumatic needle with introducer
3. 3.Spinocan 25 G (0.5 mm) cutting needle

Conditions

Post-Lumbar Puncture Headache

Keywords

Lumbar puncture; Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Odds ratio for post-lumbar puncture headache (severe)

  Up to 14 days after LP

• Headache duration (days)

  Until cessation, up to 14 days after LP

• Proportion using analgesia

  During post-lumbar puncture headache, up to 14 days after LP

• Proportion on sick leave

  During post-lumbar puncture headache, up to 14 days after LP

• Proportion with back pain

  Up to 14 days after LP

Other Outcomes (3)

• Procedure duration (minutes)

  During the lumbar puncture

• Proportion undergoing needle switch

  During the lumbar puncture

• Opening pressure (cm H2O)

  During the lumbar puncture

Study Arms (6)

Sprotte 25G needle, stylet reinserted

EXPERIMENTAL

Device: Sprotte 25G needle, stylet reinserted

Sprotte 25G needle, stylet not reinserted

EXPERIMENTAL

Device: Sprotte 25G needle, stylet not reinserted

Sprotte 22G needle, stylet reinserted

EXPERIMENTAL

Device: Sprotte 22G needle, stylet reinserted

Sprotte 22G needle, stylet not reinserted

EXPERIMENTAL

Device: Sprotte 22G needle, stylet not reinserted

Spinocan 25G needle, stylet reinserted

EXPERIMENTAL

Device: Spinocan 25G needle, stylet reinserted

Spinocan 25G needle, stylet not reinserted

EXPERIMENTAL

Device: Spinocan 25G needle, stylet not reinserted

Interventions

Sprotte 25G needle, stylet reinserted DEVICE

Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal

Sprotte 25G needle, stylet reinserted

Sprotte 25G needle, stylet not reinserted DEVICE

Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal

Sprotte 25G needle, stylet not reinserted

Sprotte 22G needle, stylet reinserted DEVICE

Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal

Sprotte 22G needle, stylet reinserted

Sprotte 22G needle, stylet not reinserted DEVICE

Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal

Sprotte 22G needle, stylet not reinserted

Spinocan 25G needle, stylet reinserted DEVICE

Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal

Spinocan 25G needle, stylet reinserted

Spinocan 25G needle, stylet not reinserted DEVICE

Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal

Spinocan 25G needle, stylet not reinserted

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects unable to participate in the study follow-up

Sponsors & Collaborators

• Jonatan Salzer: lead
• Umeå University: collaborator

Related Publications (6)

• 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.

  PMID: 11061243 BACKGROUND

• Hyllienmark L, Zachau AC. [Diagnostic lumbal puncture]. Lakartidningen. 2008 Oct 8-14;105(41):2844-9. No abstract available. Swedish.

  PMID: 19009898 BACKGROUND

• 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.

  PMID: 16116106 BACKGROUND

• 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.

  PMID: 9102578 BACKGROUND

• 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.

  PMID: 21549395 BACKGROUND

• 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.

  PMID: 11756618 BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache; Headache

Interventions

Needles

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants are not informed about the allocated needle. The follow-up telephone calls (outcome assessment) are made by an assistant nurse who is unaware of randomization allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, parallel group. Randomization between three different lumbar puncture needles and between stylet reinsertion of not before needle withdrawal.

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 23, 2019
• Study Start: May 28, 2013
• Primary Completion: June 24, 2018
• Study Completion: October 11, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share