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

SPPLAASH Study : a Randomized Study Aiming at Evaluating the Incidence of Post Lumbar Puncture Headache (PLPH) With the Use of Atraumatic Needles in Hematology

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Leukemia
• Intervention / Treatment: Device: Standard needle; Device: Atraumatic needle

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69000
    • Centre Leon Berard
  • Saint-Étienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 CHU of Saint-Etienne. 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 Names: Vygon 181.95

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of headache	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.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of headache	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.	5 days
Duration of significant headache	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.	5 days
Pain intensity	Local and immediate Intensity Pain during lumbar puncture will be reported for each patient. Intensity is evaluated by verbal rating scale.	5 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Institut de Cancérologie de la Loire

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2017
• Primary Completion (ACTUAL): October 20, 2020
• Study Completion (ACTUAL): October 31, 2020

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (ACTUAL): April 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Lumbar puncture; Haematology; Post lumbar puncture headache; Atraumatic needle
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: 2017-0302 (Other Identifier: M D Anderson Cancer Center); 2017-A00915-48 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No