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

The University of Texas System (UT)

Status

Enrolling

Conditions

Post-Lumbar Puncture Headache

Treatments

Procedure: Modified Lumbar Puncture

Study type

Interventional

Funder types

Other

Identifiers

NCT06062446

HSC-MS-23-0732

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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