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A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients

RecruitingNAAges 18 Years - anyAllThe University of Texas Health Science Center, Ho…
NCT06062446 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to o determine whether the modified LP procedure reduces the incidence of PLPH to 5% or lower, to determine whether the modified LP procedure reduces the frequency of epidural blood patch (EBP) usage to 10% or lower of the PLPH population and to identify factors that may contribute to or reduce incidence of PLPH

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participants who can sign informed consent * Participants who have stated willingness to comply with all study procedures and availability for the duration of the study * Participants receiving a LP per standard of care (SOC) need for diagnostic or therapeutic purposes only * Participants with Karnofsky Performance Scale (KPS) ≥ 60 Exclusion Criteria: * Participants with a past medical history of chronic headaches (≥15 days per month) or acute headaches * Participants with recent neurosurgical device implants such as ventriculoperitoneal shunt * Participants with more than one dural puncture during the same LP procedure * Participants have chronic coagulopathy with elevated prothrombin time (PT), Partial thromboplastin time (PTT), and International Normalized ration (INR). * Participants who are on active anticoagulant or antiplatelet therapy unless stopped such therapy prior to LP per SOC guidance. * Participants with suspicions of raised intracranial pressure by either clinical assessment or imaging assessment or both * Participants with severe spinal column deformities, such as scoliosis. Disc diseases are not exclusion criteria * Participants with LP procedural complications that require a needle type or needle size change
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What it tests

  • Modified Lumbar Puncture
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Where

1 site
The University of Texas Health Science Center at Houston
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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