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

Recruiting now · Not applicable

Conditions studied: Post-Lumbar Puncture Headache

In brief

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 facts

Study ID

NCT06062446

Run by

The University of Texas Health Science Center, Houston

People needed

100

Starts

2023-11-08

Expected to finish

2026-04-01

Last updated by the study team

2025-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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