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

Backache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01481922
• Other study ID #: NEU-11-001
• Status: Recruiting
• Phase: Phase 4
• First received: November 15, 2011
• Last updated: October 30, 2012
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: October 2012
• Source: McGill University
• Contact: Matthieu Vincent, MD, CCFP(EM)
• Phone: 450-651-8287
• Email: matthieu_vincent[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Backache
• Headache
• Post-Dural Puncture Headache
• Post-lumbar Puncture Headache

Intervention

Device:
• whitacre 24 gauge
Whitacre 24 gauge spinal needle 3 inches 1/2. Manufactured by Becton Dickinson
• whitacre 22 gauge
Whitacre 22 gauge spinal needle 3 inches 1/2 manufactured by Becton Dickinson

Locations

Country	Name	City	State
Canada	Montreal Neurological Hospital and Institute	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	funding: McGill Emergency Medicine 2010 Grant Competition

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

Carson D, Serpell M. Choosing the best needle for diagnostic lumbar puncture. Neurology. 1996 Jul;47(1):33-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of attempts	The number of attempts before collection of CSF is successful will be recorded	during the LP	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No