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Recruiting NCT06062446

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

Trial Parameters

Condition Post-Lumbar Puncture Headache
Sponsor The University of Texas Health Science Center, Houston
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-08
Completion 2026-04-01
Interventions
Modified Lumbar Puncture

Brief 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 Criteria

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

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