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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06062446
Status
Recruiting
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Conditions

  • Post-Lumbar Puncture Headache

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modified Lumbar Puncture — PROCEDURE
    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).

Study Details

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

Key Dates

Start date
Nov 8, 2023
Status verified
Jun 2025
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Modified Lumbar Puncture

Primary Outcome Measure

Number of participants with headaches as assessed by a questionnaire [ Time Frame: 30-60 minutes after LP ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Jay-Jiguang Zhu, MD,PhD
[email protected]
(713) 486-8000
Austin Lu
[email protected]
(713) 486-7758

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By research site
The University of Texas Health Science Center at Houston· Houston, TX