A Randomized Study Evaluating the Incidence of Post Lumbar Puncture Headache With Atraumatic Needles in Hematology (SPPLAASH)

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Lymphoma

Leukemia

Treatments

Device: Standard needle

Device: Atraumatic needle

Study type

Interventional

Funder types

Other

Identifiers

NCT03126045

2017-0302

2017-A00915-48 (Other Identifier)

Details and patient eligibility

About

Lumbar punctures are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache is a common complication for patients and is characterized by the occurrence of a headache with an orthostatic component, with additional symptoms such as nausea. Some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for post lumbar puncture headache while using atraumatic needles as compared to standard needles. In this context, it is necessary to better document the incidence of post lumbar puncture headache with the use of atraumatic needles in hematologic patients.

Full description

Lumbar punctures (LP) are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache (PLPH) is a common complication in around 30% of patients. PLPH is characterized by the occurrence of a headache with an orthostatic component within 12-72 hours after LP with additional symptoms such as nausea. Even if this phenomenon spontaneously resolves within 3 to 5 days, symptoms can immobilize the patient and can interfere with his daily activities. Technical procedures largely influence the incidence of PLPH. Indeed, some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for PLHP while using atraumatic needles as compared to standard needles. So far, few data are available for hematology. In this context, it is necessary to better document the incidence of PLPH with the use of atraumatic needles in hematologic patients.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with hematologic syndromes undergoing a diagnostic lumbar puncture
Signed written informed consent form
Patient affiliated to a social security regimen or beneficiary of the same

Exclusion criteria

Any known contraindication for the lumbar puncture procedure: increased intracranial pressure, blood clotting disorder, thrombocytopenia
Any known infection
Patient with a Body Mass index < 18 or Body Mass index > 40
Any patient that requires an ultrasound guided lumbar puncture
Patient that underwent a lumbar puncture within 6 months
Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. L.1121-6, L.112-7, L.1211-8, L.1211-9)
Refusing participation
Pregnancy or breastfeeding women