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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Eligibility

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

Study details
    Post-Lumbar Puncture Headache

NCT06062446

The University of Texas Health Science Center, Houston

24 June 2025

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