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

Should Physicians Use a 24 Gauge Spinal Needle Instead of a 22 Gauge When Performing a 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.

Study Overview

• Status: Completed
• Conditions: Backache; Post-lumbar Puncture Headache
• Intervention / Treatment: Device: whitacre 22 gauge; Device: whitacre 24 gauge

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Hospital and Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Product number: 405133

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to collect 5 ml of CSF	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.	after 5 ml of CSF is retrieved

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to collect 7 ml of CSF	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.	after 7 ml of CSF is retrieved
Time to collect 8 ml of CSF	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.	after 8 ml of CSF is retrieved
Time to collect 9 ml of CSF	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.	after 9 ml of CSF is retrieved
Time to collect 10 ml of CSF	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.	after 10 ml of CSF is retrieved
Time to collect 6 ml of CSF	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.	after 6 ml of CSF is retrieved
Time to collect 11 ml of CSF	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.	after 11 ml of CSF is retrieved
Time to collect 12 ml of CSF	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.	after 12 ml of CSF is retrieved
Time to collect 13 ml of CSF	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.	after 13 ml of CSF is retrieved
Time to collect 15 ml of CSF	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.	after 15 ml of CSF is retrieved
Backache first 8 days after the lumbar puncture (LP)	The presence of backache since the LP will be assessed by phone call by a blinded research assistant.	Assessed at 8 days after the LP
Severity of backache first 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)	Assessed at 8 days after the LP
Severity of backache first 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)	Assessed at 15 days after the LP
Backache first 15 days after the LP	The presence of backache since the LP will be assessed by phone call by a blinded research assistant.	Assessed at 15 days after the LP
Post-lumbar puncture headache (PLPH) at 8 days	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.	8 days after the LP
Post-lumbar puncture headache (PLPH) at 15 days	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 days after the LP
Severity of the post-lumbar puncture headache (PLPH) at 8 days	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.	8 days after the LP
Severity of the post-lumbar puncture headache (PLPH) at 15 days	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.	15 days after the LP
Time to get CSF	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	During the LP
Extra time patients are willing to spend - part 1	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	immediately after the LP
Extra time patients are willing to spend - part 2	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	8 days after LP
Extra time patients willing to spend - part 3	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	15 days after LP
Pain related to 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)	Immediately after LP
Number of attempts	The number of attempts before collection of CSF is successful will be recorded	during the LP
Medical attention for PLPH	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.	at 15 days
Medical attention for backache	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.	at 8 days
Medical attention for backache	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.	at 15 days
Medical treatment for PLPH	Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their PLPH (eg. analgesics).	8 days
Medical treatment for PLPH	Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their PLPH (eg. analgesics)	15 days
Medical treatment for backache	Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their backache(eg. analgesics)	8 days
Medical treatment for backache	Patient will be asked by phone by a blinded research assistant if they received a medical treatment for their backache(eg. analgesics)	15 days
Epidural blood patch for PLPH	Patients will be asked by phone by a blinded research assistant if they received an epidural blood patch for PLPH.	at 8 days
Epidural blood patch for PLPH	Patients will be asked by phone by a blinded research assistant if they received an epidural blood patch for PLPH.	at 15 days
Undifferentiated headache at 8 days	The presence of any headache since the LP will be assessed by phone call by a blinded research assistant.	8 days after the LP
Undifferentiated headache at 15 days	The presence of any headache since the LP will be assessed by phone call by a blinded research assistant.	15 days after the LP
Hearing loss	The presence of subjective hearing loss will be recorded at 8 days by a phone call by a blinded research assistant	8 days after LP
Hearing loss	The presence of subjective hearing loss will be recorded at 8 days by a phone call by a blinded research assistant	15 days after LP
Time to collect 14 ml of CSF	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.	after 14 ml of CSF is retrieved
Medical attention for PLPH	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.	at 8 days

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: funding: McGill Emergency Medicine 2010 Grant Competition
• Investigators: Principal Investigator: Liam Durcan, MD, FRCP(c), Montreal Neurological Hospital and Institute, McGill University

Publications and helpful links

General Publications

• Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. doi: 10.1212/01.wnl.0000173034.96211.1b.
• Abouleish E, Mitchell M, Taylor G, Miller H, Warters D, Rashad MN. Comparative flow rates of saline in commonly used spinal needles including pencil-tip needles. Reg Anesth. 1994 Jan-Feb;19(1):34-42.
• Carson D, Serpell M. Choosing the best needle for diagnostic lumbar puncture. Neurology. 1996 Jul;47(1):33-7. doi: 10.1212/wnl.47.1.33.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (ESTIMATE): November 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 22, 2016
• Last Update Submitted That Met QC Criteria: March 19, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Pain; Lumbar puncture; Backache; Flow rate; Undifferentiated headache; Post-lumbar puncture headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Back Pain; Wounds and Injuries; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: NEU-11-001