Clinical trial · Interventional
A Randomized Study Evaluating the Incidence of Post Lumbar Puncture Headache With Atraumatic Needles in Hematology
SPPLAASH Study : a Randomized Study Aiming at Evaluating the Incidence of Post Lumbar Puncture Headache (PLPH) With the Use of Atraumatic Needles in Hematology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atraumatic needle | Device | — | UNRESOLVED |
| Standard needle | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard needle
- description
- Patients perform a spinal punction according to the usual practice, with a standard needle.
- interventionNames
- Device: Standard needle
- type
- EXPERIMENTAL
- label
- Atraumatic needle
- description
- Patients perform a spinal punction according to the usual practice, with an atraumatic needle.
- interventionNames
- Device: Atraumatic needle
Primary outcomes (1)
- measure
- Number of headache
- timeFrame
- 5 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available