SPPLAASH Study : a Randomized Study Aiming at Evaluating the Incidence of Post Lumbar Puncture Headache (PLPH) With the Use of Atraumatic Needles in Hematology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 68
- Locations
- 2
- Primary Endpoint
- Number of headache
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Neither patients know the needle used during the spinal punction, nor the person collecting the information.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard needle
Patients perform a spinal punction according to the usual practice, with a standard needle.
Intervention: Standard needle (Device)
Atraumatic needle
Patients perform a spinal punction according to the usual practice, with an atraumatic needle.
Intervention: Atraumatic needle (Device)
Outcomes
Primary Outcomes
Number of headache
Time Frame: 5 days
Incidence of patients with mild and severe headache within 5 days following lumbar puncture as evaluated by verbal rating scales (intensity score ≥4) will be reported.
Secondary Outcomes
- Intensity of headache(5 days)
- Duration of significant headache(5 days)
- Pain intensity(5 days)