search
Back to results

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
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
April 20, 2017
Last Updated
February 7, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Institut de Cancérologie de la Loire
search

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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
No
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
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs