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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 XX - Participants with LP procedural complications that require a needle type or needle size change

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Modified Lumbar Puncture
  • Procedure: Modified 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).

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Jay-Jiguang Zhu, MD,PhD
713-486-8000
Jay.Jiguang.Zhu@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Jay-Jiguang Zhu, MD,PhD
(713) 486-8000
Jay.Jiguang.Zhu@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.