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

Primary Purpose

Leukemia, Lymphoma

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Standard needle

Atraumatic needle

About this trial

This is an interventional prevention trial for Leukemia focused on measuring Lumbar puncture, Post lumbar puncture headache, Atraumatic needle, Haematology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Léon Bérard
CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard needle

Atraumatic needle

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Pain intensity

Local and immediate Intensity Pain during lumbar puncture will be reported for each patient. Intensity is evaluated by verbal rating scale.

Full Information

NCT ID

NCT03126045

First Posted

April 20, 2017

Last Updated

February 7, 2022

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Institut de Cancérologie de la Loire

1. Study Identification

Unique Protocol Identification Number

NCT03126045

Brief Title

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

Acronym

SPPLAASH

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

August 22, 2017 (Actual)

Primary Completion Date

October 20, 2020 (Actual)

Study Completion Date

October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Institut de Cancérologie de la Loire

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Lymphoma

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Arm 1: standard needle Arm 2: Atraumatic needle

Masking

ParticipantOutcomes Assessor

Masking Description

Neither patients know the needle used during the spinal punction, nor the person collecting the information.

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard needle

Arm Type

Active Comparator

Arm Description

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

Arm Title

Atraumatic needle

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Standard needle

Other Intervention Name(s)

BD Yale 405256

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Atraumatic needle

Other Intervention Name(s)

Vygon 181.95

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of headache

Description

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.

Time Frame

5 days

Secondary Outcome Measure Information:

Title

Intensity of headache

Description

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.

Time Frame

5 days

Title

Duration of significant headache

Description

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.

Time Frame

5 days

Title

Pain intensity

Description

Local and immediate Intensity Pain during lumbar puncture will be reported for each patient. Intensity is evaluated by verbal rating scale.

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Denis Guyotat, PhD

Organizational Affiliation

CHU de Saint-Etienne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69000

Country

France

Facility Name

CHU de Saint-Etienne

City

Saint-Étienne

ZIP/Postal Code

42055

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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