What Needle Diameter Should Physician Use When They Perform Lumbar Puncture ? A Randomized Controlled Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by McGill University
Sponsor:
Collaborator:
funding: McGill Emergency Medicine 2010 Grant Competition
Information provided by (Responsible Party):
Liam Durcan, McGill University
ClinicalTrials.gov Identifier:
NCT01481922
First received: November 15, 2011
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

This study is intended to help guide the choice of needle diameter when performing a lumbar puncture.

Smaller spinal needles have been shown to decrease rate of adverse events such as post-lumbar puncture headache and hearing loss.

The main drawback to using smaller needles is diminished flow rate; some textbooks recommend using needles no smaller than 22 gauge because of the slow flow rate though others recommend smaller needles, namely 22-24 gauge.

Some authors have described a successful use of spinal needles as small as 25 gauge when performing a lumbar puncture.

The investigators do not believe that the flow-rate difference between 22 and 24 gauge needles is significant enough to justify using the larger needles.

The investigators trial will compare the Whitacre 22 gauge and Whitacre 24 gauge needles for flow rate, and incidence of the known complications of pain during procedure and backache at 8 and 15 days post-procedure.

The investigators will also look at whether smaller needles are associated with less pain during the procedure and less backache the next 2 weeks after the procedure.


Condition Intervention Phase
Post-lumbar Puncture Headache
Backache
Device: whitacre 24 gauge
Device: whitacre 22 gauge
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Should Physicians Use a 24 Gauge Spinal Needle Instead of a 22 Gauge When Performing a Lumbar Puncture ? A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Time to collect 5 ml of CSF [ Time Frame: after 5 ml of CSF is retrieved ] [ Designated as safety issue: No ]
    Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 5 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 5ml, the time will be adjusted accordingly to reflect collection of exactly 5ml.


Secondary Outcome Measures:
  • Time to collect 7 ml of CSF [ Time Frame: after 7 ml of CSF is retrieved ] [ Designated as safety issue: No ]
    Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 7 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 7 ml, the time will be adjusted accordingly to reflect collection of exactly 7 ml.

  • Time to collect 8 ml of CSF [ Time Frame: after 8 ml of CSF is retrieved ] [ Designated as safety issue: No ]
    Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 8 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 8 ml, the time will be adjusted accordingly to reflect collection of exactly 8 ml.

  • Time to collect 9 ml of CSF [ Time Frame: after 9 ml of CSF is retrieved ] [ Designated as safety issue: No ]
    Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 9 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 9 ml, the time will be adjusted accordingly to reflect collection of exactly 9 ml.

  • Time to collect 10 ml of CSF [ Time Frame: after 10 ml of CSF is retrieved ] [ Designated as safety issue: Yes ]
    Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 10 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 10 ml, the time will be adjusted accordingly to reflect collection of exactly 10 ml.

  • Time to collect 6 ml of CSF [ Time Frame: after 6 ml of CSF is retrieved ] [ Designated as safety issue: No ]
    Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 6 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 6 ml, the time will be adjusted accordingly to reflect collection of exactly 6 ml.

  • Time to collect 11 ml of CSF [ Time Frame: after 11 ml of CSF is retrieved ] [ Designated as safety issue: No ]
    Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 11 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 11 ml, the time will be adjusted accordingly to reflect collection of exactly 11 ml.

  • Time to collect 12 ml of CSF [ Time Frame: after 12 ml of CSF is retrieved ] [ Designated as safety issue: No ]
    Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 12 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 12 ml, the time will be adjusted accordingly to reflect collection of exactly 12 ml.

  • Time to collect 13 ml of CSF [ Time Frame: after 13 ml of CSF is retrieved ] [ Designated as safety issue: No ]
    Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 13 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 13 ml, the time will be adjusted accordingly to reflect collection of exactly 13 ml.

  • Time to collect 15 ml of CSF [ Time Frame: after 15 ml of CSF is retrieved ] [ Designated as safety issue: No ]
    Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 15 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 15 ml, the time will be adjusted accordingly to reflect collection of exactly 15 ml.

  • Backache first 8 days after the lumbar puncture (LP) [ Time Frame: Assessed at 8 days after the LP ] [ Designated as safety issue: Yes ]
    The presence of backache since the LP will be assessed by phone call by a blinded research assistant.

  • Severity of backache first 8 days after the LP [ Time Frame: Assessed at 8 days after the LP ] [ Designated as safety issue: Yes ]

    The severity of the backache (when present) will be assessed at 8 days by a phone call by a blinded research assistant.

    A numerical rating scale will be used (0-10)


  • Severity of backache first 15 days after the LP [ Time Frame: Assessed at 15 days after the LP ] [ Designated as safety issue: Yes ]

    The severity of the backache (when present) will be assessed at 15 days by a phone call by a blinded research assistant.

    A numerical rating scale will be used (0-10)


  • Backache first 15 days after the LP [ Time Frame: Assessed at 15 days after the LP ] [ Designated as safety issue: Yes ]
    The presence of backache since the LP will be assessed by phone call by a blinded research assistant.

  • Post-lumbar puncture headache (PLPH) at 8 days [ Time Frame: 8 days after the LP ] [ Designated as safety issue: Yes ]
    The presence of PLPH since the LP will be assessed by phone call by a blinded research assistant. The International Headache Society definition of PLPH will be used.

  • Post-lumbar puncture headache (PLPH) at 15 days [ Time Frame: 15 days after the LP ] [ Designated as safety issue: Yes ]
    The presence of PLPH since the LP will be assessed by phone call by a blinded research assistant. The International Headache Society definition of PLPH will be used.

  • Severity of the post-lumbar puncture headache (PLPH) at 8 days [ Time Frame: 8 days after the LP ] [ Designated as safety issue: Yes ]
    The severity of PLPH (when present) will be assessed by phone call by a blinded research assistant. A numerical rating scale (0-10) will be used.

  • Severity of the post-lumbar puncture headache (PLPH) at 15 days [ Time Frame: 15 days after the LP ] [ Designated as safety issue: Yes ]
    The severity of PLPH (when present) will be assessed by phone call by a blinded research assistant. A numerical rating scale (0-10) will be used.

  • Time to get CSF [ Time Frame: During the LP ] [ Designated as safety issue: No ]
    The time required to get a successful LP will be measured. Start time (T=0s) will be the first contact of the spinal needle with the skin. Stop time will be when the first drop of CSF drips out of the needle hub

  • Extra time patients are willing to spend - part 1 [ Time Frame: immediately after the LP ] [ Designated as safety issue: No ]
    Patients will be asked right after the LP by a blinded research assistant how much more time they would have been willing to spend for an LP if it could reduce the rate of PLPH and hearing loss

  • Extra time patients are willing to spend - part 2 [ Time Frame: 8 days after LP ] [ Designated as safety issue: No ]
    Patients will be asked 8 days after the LP by a blinded research assistant how much more time they would have been willing to spend for an LP if it could reduce the rate of PLPH and hearing loss Subgroup analysis will be done for patient who developed PLPH

  • Extra time patients willing to spend - part 3 [ Time Frame: 15 days after LP ] [ Designated as safety issue: No ]
    Patients will be asked 15 days after the LP by a blinded research assistant how much more time they would have been willing to spend for an LP if it could reduce the rate of PLPH and hearing loss Subgroup analysis will be done for patient who developed PLPH

  • Pain related to LP [ Time Frame: Immediately after LP ] [ Designated as safety issue: No ]
    The severity of the pain related to the LP will be assessed by a blinded research assistant using a visual analogue scale (0-10)

  • Number of attempts [ Time Frame: during the LP ] [ Designated as safety issue: No ]
    The number of attempts before collection of CSF is successful will be recorded

  • Medical attention for PLPH [ Time Frame: at 15 days ] [ Designated as safety issue: No ]
    The need for patients to get medical assistance regarding a PLPH will be recorded (as defined by: a visit to health-care provider, admission to hospital, or a phone call to a health-care provider). This will be determined by a phone call at 15 days by a blinded research assistant.

  • Medical attention for backache [ Time Frame: at 8 days ] [ Designated as safety issue: No ]
    The need for patients to get medical assistance regarding a backache will be recorded (as defined by: a visit to health-care provider, admission to hospital, or a phone call to a health-care provider). This will be determined by a phone call at 8 days by a blinded research assistant.

  • Medical attention for backache [ Time Frame: at 15 days ] [ Designated as safety issue: No ]
    The need for patients to get medical assistance regarding a backache will be recorded (as defined by: a visit to a health-care provider, admission to hospital, or a phone call to a health-care provider). This will be determined by a phone call at 15 days by a blinded research assistant.

  • Medical treatment for PLPH [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their PLPH (eg. analgesics).

  • Medical treatment for PLPH [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their PLPH (eg. analgesics)

  • Medical treatment for backache [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their backache(eg. analgesics)

  • Medical treatment for backache [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their backache(eg. analgesics)

  • Epidural blood patch for PLPH [ Time Frame: at 8 days ] [ Designated as safety issue: No ]
    Patients will be asked by phone by a blinded research assistant if they received an epidural blood patch for PLPH.

  • Epidural blood patch for PLPH [ Time Frame: at 15 days ] [ Designated as safety issue: No ]
    Patients will be asked by phone by a blinded research assistant if they received an epidural blood patch for PLPH.

  • Undifferentiated headache at 8 days [ Time Frame: 8 days after the LP ] [ Designated as safety issue: Yes ]
    The presence of any headache since the LP will be assessed by phone call by a blinded research assistant.

  • Undifferentiated headache at 15 days [ Time Frame: 15 days after the LP ] [ Designated as safety issue: Yes ]
    The presence of any headache since the LP will be assessed by phone call by a blinded research assistant.

  • Hearing loss [ Time Frame: 8 days after LP ] [ Designated as safety issue: Yes ]
    The presence of subjective hearing loss will be recorded at 8 days by a phone call by a blinded research assistant

  • Hearing loss [ Time Frame: 15 days after LP ] [ Designated as safety issue: Yes ]
    The presence of subjective hearing loss will be recorded at 8 days by a phone call by a blinded research assistant

  • Time to collect 14 ml of CSF [ Time Frame: after 14 ml of CSF is retrieved ] [ Designated as safety issue: No ]
    Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 14 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 14 ml, the time will be adjusted accordingly to reflect collection of exactly 14 ml.

  • Medical attention for PLPH [ Time Frame: at 8 days ] [ Designated as safety issue: No ]
    The need for patients to get medical assistance regarding a PLPH will be recorded (as defined by: a visit to health-care provider, admission to hospital, or a phone call to a health-care provider). This will be determined by a phone call at 8 days by a blinded research assistant.


Estimated Enrollment: 62
Study Start Date: November 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Whitacre 22 gauge
lumbar puncture performed with a Whitacre 22 gauge (BD)
Device: whitacre 22 gauge
Whitacre 22 gauge spinal needle 3 inches 1/2 manufactured by Becton Dickinson
Other Name: product number 405010
Experimental: Whitacre 24 gauge
lumbar puncture performed with a Whitacre 24 gauge (BD)
Device: whitacre 24 gauge
Whitacre 24 gauge spinal needle 3 inches 1/2. Manufactured by Becton Dickinson
Other Name: Product number: 405133

Detailed Description:

The purpose of this randomized, double-blinded clinical trial is to assess whether a 24 gauge spinal needle can provide an acceptable flow rate of cerebrospinal fluid (CSF) when compared to the traditionally used 22 gauge needle.

Smaller needles, according to The Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology are 'associated with reduced frequency of post-lumbar puncture headache (Level A recommendation).'

Given that flow rate of CSF is the limiting factor when choosing a spinal needle gauge, two previous studies have compared various needle sizes for adequacy of flow. These studies, however, have important limitations and have not led to a clear consensus in clinical practice. For instance, one study used a 0,9 % solution of sodium chloride at room temperature, the other used an 'artificial CSF solution' of unknown viscosity and nature.

Patients referred to the neurological day center of the Montreal Neurological Institute/Hospital for lumbar puncture will be recruited to the study. Participants will be randomized to have the puncture with a Whitacre 22 or 24 gauge needle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients (>= 18 years old) referred at the Neurological Day Center to get a lumbar puncture

Exclusion Criteria:

  • Contraindication to get a lumbar puncture
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481922

Contacts
Contact: Matthieu Vincent, MD, CCFP(EM) 450-651-8287 matthieu_vincent@hotmail.com
Contact: Liam Durcan, MD, FRCP(c) 514-398-5034 liam.durcan@mcgill.ca

Locations
Canada, Quebec
Montreal Neurological Hospital and Institute Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Matthieu Vincent, MD, CCFP(EM)    450-651-8287    matthieu_vincent@hotmail.com   
Contact: Liam Durcan, MD, FRCP(c)    514-398-5034    liam.durcan@mcgill.ca   
Sub-Investigator: Matthieu Vincent, MD, CCFP(EM)         
Principal Investigator: Liam Durcan, MD, FRCP(c)         
Sponsors and Collaborators
McGill University
funding: McGill Emergency Medicine 2010 Grant Competition
Investigators
Principal Investigator: Liam Durcan, MD, FRCP(c) Montreal Neurological Hospital and Institute, McGill University
  More Information

Publications:
Responsible Party: Liam Durcan, MD, FRCPc, Neurologist-in-Chief, Montreal Neurological Hospital Interim Clinical Director, Neurology, McGill University Health Center, McGill University
ClinicalTrials.gov Identifier: NCT01481922     History of Changes
Other Study ID Numbers: NEU-11-001
Study First Received: November 15, 2011
Last Updated: October 30, 2012
Health Authority: Canada: Health Canada

Keywords provided by McGill University:
Lumbar puncture
Flow rate
Backache
Pain
Undifferentiated headache
Post-lumbar puncture headache

Additional relevant MeSH terms:
Back Pain
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

ClinicalTrials.gov processed this record on August 28, 2014