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

Study Overview
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Brief Summary
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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

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

Conditions
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Post-Lumbar Puncture Headache

Intervention / Treatment
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* Procedure: Modified Lumbar Puncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Lumbar Puncture<br> | Procedure: Modified Lumbar Puncture<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 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? | 1 day 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? | 3 days 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? | 5 days after LP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that use the epidural blood patch |  | 1 day after the LP | 
| Number of participants that use the epidural blood patch |  | 3 days after the LP | 
| Number of participants that use the epidural blood patch |  | 5 days after the LP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar puncture, headache