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

The University of Texas Health Science Center, Houston100 enrolled

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Post-Lumbar Puncture Headache

Interventions

Modified Lumbar PuncturePROCEDURE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Number of participants with headaches as assessed by a questionnaire

Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?

Time frame: 30-60 minutes after LP

Number of participants with headaches as assessed by a questionnaire

Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?

Time frame: 1 day after LP

Number of participants with headaches as assessed by a questionnaire

Time frame: 3 days after LP

Number of participants with headaches as assessed by a questionnaire

Time frame: 5 days after LP

Secondary Outcomes

Number of participants that use the epidural blood patch

Time frame: 1 day after the LP

Number of participants that use the epidural blood patch

Time frame: 3 days after the LP

Number of participants that use the epidural blood patch

Central Contacts

Jay-Jiguang Zhu, MD,PhD

CONTACT

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

Austin Lu

CONTACT

(713) 486-7758 Austin.Lu@uth.tmc.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.