Actively Recruiting
A Study of a Modified Lumbar Puncture Procedure to Reduce Post-Lumbar Puncture Headaches in Adults
Led by The University of Texas Health Science Center, Houston · Updated on 2025-06-13
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a modified lumbar puncture (LP) procedure designed to reduce the occurrence of post-lumbar puncture headaches (PLPH) in adult patients. This study aims to determine if this modified procedure can lower the incidence of PLPH to 5% or less, reduce the use of epidural blood patches (EBP) to 10% or less among those with PLPH, and identify factors influencing PLPH occurrence. The modified LP procedure involves using a 22 gauge Quincke spinal needle without reinserting the stylet after cerebrospinal fluid collection before removing the needle. Participants will undergo this modified procedure as part of their diagnostic or therapeutic care. The study is prospective and single-arm, focusing on adult patients receiving lumbar punctures according to standard medical care. Participants will be assessed for headaches at multiple time points: 30 to 60 minutes, 1 day, 3 days, and 5 days after the procedure using questionnaires. Use of epidural blood patches will also be tracked at 1, 3, and 5 days post-LP. Participants must be able to consent and comply with study procedures, with their performance status considered. The total duration and follow-up details align with the scheduled assessments after the LP procedure.
CONDITIONS
Brief Title
A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 lumbar puncture per standard of care for diagnostic or therapeutic purposes
- Participants with Karnofsky Performance Scale (KPS) of 60 or higher
You will not qualify if you...
- Participants with a history of chronic headaches occurring 15 or more 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 lumbar puncture procedure
- Participants with chronic coagulopathy with elevated PT, PTT, or INR
- Participants on active anticoagulant or antiplatelet therapy unless stopped prior to lumbar puncture per standard care
- Participants suspected of raised intracranial pressure by clinical or imaging assessment
- Participants with severe spinal column deformities such as scoliosis (disc diseases are not exclusion criteria)
- Participants with lumbar puncture procedural complications requiring needle type or size change
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day with follow-up assessments up to 5 days
Participants undergo the modified lumbar puncture procedure using a specific technique to reduce post-lumbar puncture headaches.
1 procedure visit and 4 follow-up visits (30-60 minutes, Day 1, Day 3, and Day 5 after the procedure)
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jay-Jiguang Zhu, MD,PhD
A
Austin Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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