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

This study is currently recruiting participants.
Verified September 2017 by Institut de Cancérologie de la Loire
Sponsor:
ClinicalTrials.gov Identifier:
NCT03126045
First Posted: April 24, 2017
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire
  Purpose
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.

Condition Intervention
Leukemia Lymphoma Device: Standard needle Device: Atraumatic needle

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Arm 1: standard needle Arm 2: Atraumatic needle
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Neither patients know the needle used during the spinal punction, nor the person collecting the information.
Primary Purpose: Prevention
Official Title: SPPLAASH Study : a Randomized Study Aiming at Evaluating the Incidence of Post Lumbar Puncture Headache (PLPH) With the Use of Atraumatic Needles in Hematology

Resource links provided by NLM:


Further study details as provided by Institut de Cancérologie de la Loire:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Intensity of headache [ Time Frame: 5 days ]
    Maximum intensity of headache as evaluated by verbal rating scale (scoring from 0 to 10) within 5 days following lumbar puncture will be reported for each patient.

  • Duration of significant headache [ Time Frame: 5 days ]
    Duration in days of mild and severe headache (verbal rating scale score ≥ 4) within 5 days following lumbar puncture will be reported for each patient.

  • Pain intensity [ Time Frame: 5 days ]
    Local and immediate Intensity Pain during lumbar puncture will be reported for each patient. Intensity is evaluated by verbal rating scale.


Estimated Enrollment: 68
Actual Study Start Date: August 22, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard needle
Patients perform a spinal punction according to the usual practice, with a standard needle.
Device: Standard needle

Patients will perform a spinal punction with a standard needle, used in the usual practice. The standard needles have the following characteristics : BD 22 G x 3 ½ in, 90mm, Quincke spinal needle, Black hub.

When more than 2 attempts for lumbar puncture fail, the investigator will proceed with standard techniques (BD 20G x 3 ½ in, Quincke spinal needle, 90mm, yellow hub). This is a failed lumbar puncture.

Other Name: BD Yale 405256
Experimental: Atraumatic needle
Patients perform a spinal punction according to the usual practice, with an atraumatic needle.
Device: Atraumatic needle

Patients will perform a spinal punction with an atraumatic needle, used in the hematological service of the Lucien Neuwirth Cancerology Institute. The atraumatic needles have the following characteristics : Vygon 24 G × 3 ½ in, 90mm, Whitacre Pencil Point Spinal Needle, Purple hub.

When more than 2 attempts for lumbar puncture fail, the investigator will proceed with standard techniques (BD 20G x 3 ½ in, Quincke spinal needle, 90mm, yellow hub). This is a failed lumbar puncture.

Other Name: Vygon 181.95

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126045


Contacts
Contact: Denis Guyotat, PhD 4 77 91 67 28 ext +33 Denis.guyotat@icloire.fr
Contact: Ludovic Fouillet 4 77 91 70 00 ext +33 Ludovic.fouillet@icloire.fr

Locations
France
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Denis Guyotat, PhD    4 77 91 67 28 ext +33    Denis.guyotat@icloire.fr   
Principal Investigator: Denis Guyotat, PhD         
Sub-Investigator: Jérôme Cornillon, PhD         
Sub-Investigator: Caroline Lejeune, PhD         
Sub-Investigator: Christiane Mounier, PhD         
Sub-Investigator: Christelle Portois, PhD         
Sub-Investigator: Gilbert Soglu, PhD         
Sub-Investigator: Emmanuelle Tavernier, PhD         
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
Principal Investigator: Denis Guyotat, PhD Institut de Cancérologie Lucien Neuwirth
  More Information

Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT03126045     History of Changes
Other Study ID Numbers: 2017-0302
2017-A00915-48 ( Other Identifier: ANSM )
First Submitted: April 20, 2017
First Posted: April 24, 2017
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut de Cancérologie de la Loire:
Lumbar puncture
Post lumbar puncture headache
Atraumatic needle
Haematology

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Menthol
Antipruritics
Dermatologic Agents