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RecruitingNot ApplicableNCT06062446

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

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

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

100 participants

Start Date

Nov 8, 2023

Study Type

INTERVENTIONAL

Conditions

Post-Lumbar Puncture Headache

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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 LP procedural complications that require a needle type or needle size change

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Interventions

PROCEDUREModified Lumbar Puncture

The Investigator will perform the modified LP procedure using the 22 Gg needles Quincke spinal needle (namely, without reinsertion of stylet into the spinal needle after cerebrospinal fluid (CSF) collection before spinal needle removal).

Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT06062446