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Completed

NCT Number: NCT01481922

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

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.

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Key information

Conditions

Post-Lumbar Puncture Headache Back Pain Backache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-Dural Puncture Headache Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montreal Neurological Hospital and Institute

Montreal, Quebec, H3A 2B4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

whitacre 24 gauge

Device

Whitacre 24 gauge spinal needle 3 inches 1/2. Manufactured by Becton Dickinson

Other names: Product number: 405133

whitacre 22 gauge

Device

Whitacre 22 gauge spinal needle 3 inches 1/2 manufactured by Becton Dickinson

Other names: product number 405010

Primary outcomes

  1. Time to collect 5 ml of CSF

    Time frame: after 5 ml of CSF is retrieved

    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 outcomes

  1. Time to collect 7 ml of CSF

    Time frame: after 7 ml of CSF is retrieved

    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.

  2. Time to collect 8 ml of CSF

    Time frame: after 8 ml of CSF is retrieved

    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.

  3. Time to collect 9 ml of CSF

    Time frame: after 9 ml of CSF is retrieved

    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.

  4. Time to collect 10 ml of CSF

    Time frame: after 10 ml of CSF is retrieved

    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.

  5. Time to collect 6 ml of CSF

    Time frame: after 6 ml of CSF is retrieved

    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.

  6. Time to collect 11 ml of CSF

    Time frame: after 11 ml of CSF is retrieved

    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.

  7. Time to collect 12 ml of CSF

    Time frame: after 12 ml of CSF is retrieved

    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.

  8. Time to collect 13 ml of CSF

    Time frame: after 13 ml of CSF is retrieved

    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.

  9. Time to collect 15 ml of CSF

    Time frame: after 15 ml of CSF is retrieved

    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.

  10. Backache first 8 days after the lumbar puncture (LP)

    Time frame: Assessed at 8 days after the LP

    The presence of backache since the LP will be assessed by phone call by a blinded research assistant.

  11. Severity of backache first 8 days after the LP

    Time frame: Assessed at 8 days after the LP

    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)

  12. Severity of backache first 15 days after the LP

    Time frame: Assessed at 15 days after the LP

    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)

  13. Backache first 15 days after the LP

    Time frame: Assessed at 15 days after the LP

    The presence of backache since the LP will be assessed by phone call by a blinded research assistant.

  14. Post-lumbar puncture headache (PLPH) at 8 days

    Time frame: 8 days after the LP

    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.

  15. Post-lumbar puncture headache (PLPH) at 15 days

    Time frame: 15 days after the LP

    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.

  16. Severity of the post-lumbar puncture headache (PLPH) at 8 days

    Time frame: 8 days after the LP

    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.

  17. Severity of the post-lumbar puncture headache (PLPH) at 15 days

    Time frame: 15 days after the LP

    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.

  18. Time to get CSF

    Time frame: During the LP

    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

  19. Extra time patients are willing to spend - part 1

    Time frame: immediately after the LP

    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

  20. Extra time patients are willing to spend - part 2

    Time frame: 8 days after LP

    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

  21. Extra time patients willing to spend - part 3

    Time frame: 15 days after LP

    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

  22. Pain related to LP

    Time frame: Immediately after LP

    The severity of the pain related to the LP will be assessed by a blinded research assistant using a visual analogue scale (0-10)

  23. Number of attempts

    Time frame: during the LP

    The number of attempts before collection of CSF is successful will be recorded

  24. Medical attention for PLPH

    Time frame: at 15 days

    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.

  25. Medical attention for backache

    Time frame: at 8 days

    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.

  26. Medical attention for backache

    Time frame: at 15 days

    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.

  27. Medical treatment for PLPH

    Time frame: 8 days

    Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their PLPH (eg. analgesics).

  28. Medical treatment for PLPH

    Time frame: 15 days

    Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their PLPH (eg. analgesics)

  29. Medical treatment for backache

    Time frame: 8 days

    Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their backache(eg. analgesics)

  30. Medical treatment for backache

    Time frame: 15 days

    Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their backache(eg. analgesics)

  31. Epidural blood patch for PLPH

    Time frame: at 8 days

    Patients will be asked by phone by a blinded research assistant if they received an epidural blood patch for PLPH.

  32. Epidural blood patch for PLPH

    Time frame: at 15 days

    Patients will be asked by phone by a blinded research assistant if they received an epidural blood patch for PLPH.

  33. Undifferentiated headache at 8 days

    Time frame: 8 days after the LP

    The presence of any headache since the LP will be assessed by phone call by a blinded research assistant.

  34. Undifferentiated headache at 15 days

    Time frame: 15 days after the LP

    The presence of any headache since the LP will be assessed by phone call by a blinded research assistant.

  35. Hearing loss

    Time frame: 8 days after LP

    The presence of subjective hearing loss will be recorded at 8 days by a phone call by a blinded research assistant

  36. Hearing loss

    Time frame: 15 days after LP

    The presence of subjective hearing loss will be recorded at 8 days by a phone call by a blinded research assistant

  37. Time to collect 14 ml of CSF

    Time frame: after 14 ml of CSF is retrieved

    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.

  38. Medical attention for PLPH

    Time frame: at 8 days

    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.

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • funding: McGill Emergency Medicine 2010 Grant Competition

Registry information

Official study title

Should Physicians Use a 24 Gauge Spinal Needle Instead of a 22 Gauge When Performing a Lumbar Puncture ? A Randomized Controlled Trial.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 30, 2011
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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