Post-Lumbar Puncture Headache
Conditions
Keywords
lumbar puncture, headache
Brief 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
Interventions
PROCEDUREModified Lumbar Puncture
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).
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with headaches as assessed by a questionnaire | 30-60 minutes after LP | 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? |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants that use the epidural blood patch | 1 day after the LP |
Countries
United States
Contacts
Primary ContactJay-Jiguang Zhu, MD,PhD
Backup ContactAustin Lu
Outcome results
None listed