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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post-lumbar Puncture Headache, Backache

Intervention / Treatment
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* Device: whitacre 24 gauge
* Device: whitacre 22 gauge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whitacre 22 gauge<br>lumbar puncture performed with a Whitacre 22 gauge (BD) | Device: whitacre 22 gauge<br>* Whitacre 22 gauge spinal needle 3 inches 1/2 manufactured by Becton Dickinson<br>* Other names: product number 405010;|
| Experimental: Whitacre 24 gauge<br>lumbar puncture performed with a Whitacre 24 gauge (BD) | Device: whitacre 24 gauge<br>* Whitacre 24 gauge spinal needle 3 inches 1/2. Manufactured by Becton Dickinson<br>* Other names: Product number: 405133;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Lumbar puncture, Flow rate, Backache, Undifferentiated headache, Post-lumbar puncture headache