NCT06062446NARecruiting
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, Houston
Start Date
11/8/2023
Completion Date
4/1/2026
Summary
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
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
PROCEDURE
Modified Lumbar Puncture
Conditions
Post-Lumbar Puncture Headache
Locations
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States