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

NCT03126045 | Completed

• 2 other identifiers: 2017-03022017-A00915-48
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Leukemia; Lymphoma

Keywords

Lumbar puncture; Post lumbar puncture headache; Atraumatic needle; Haematology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Intensity of headache

  5 days

• Duration of significant headache

  5 days

• Pain intensity

  5 days

Study Arms (2)

Standard needle

ACTIVE COMPARATOR

Patients perform a spinal punction according to the usual practice, with a standard needle.

Device: Standard needle

Atraumatic needle

EXPERIMENTAL

Patients perform a spinal punction according to the usual practice, with an atraumatic needle.

Device: Atraumatic needle

Interventions

Standard needle DEVICE

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.

Also known as: BD Yale 405256

Standard needle

Atraumatic needle DEVICE

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.

Also known as: Vygon 181.95

Atraumatic needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Institut de Cancérologie de la Loire: collaborator

Study Sites (2)

Centre Léon Bérard

Lyon, 69000, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Denis Guyotat, PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Neither patients know the needle used during the spinal punction, nor the person collecting the information.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: standard needle Arm 2: Atraumatic needle

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 24, 2017
• Study Start: August 22, 2017
• Primary Completion: October 20, 2020
• Study Completion: October 31, 2020
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)