Clinical trial NCT01481922: What Needle Diameter Should Physician Use When They Perform Lumbar Puncture ? A Randomized Controlled 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-lumbar Puncture Headache
Backache
Keywords: Lumbar puncture
Flow rate
Backache
Pain
Undifferentiated headache
Post-lumbar puncture headache
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: funding: McGill Emergency Medicine 2010 Grant Competition
First posted: 2011-11-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Time to collect 5 ml of CSF
timeFrame: after 5 ml of CSF is retrieved
Secondary outcomes:
measure: Time to collect 7 ml of CSF
timeFrame: after 7 ml of CSF is retrieved
measure: Time to collect 8 ml of CSF
timeFrame: after 8 ml of CSF is retrieved
measure: Time to collect 9 ml of CSF
timeFrame: after 9 ml of CSF is retrieved
measure: Time to collect 10 ml of CSF
timeFrame: after 10 ml of CSF is retrieved
measure: Time to collect 6 ml of CSF
timeFrame: after 6 ml of CSF is retrieved
measure: Time to collect 11 ml of CSF
timeFrame: after 11 ml of CSF is retrieved
measure: Time to collect 12 ml of CSF
timeFrame: after 12 ml of CSF is retrieved
measure: Time to collect 13 ml of CSF
timeFrame: after 13 ml of CSF is retrieved
measure: Time to collect 15 ml of CSF
timeFrame: after 15 ml of CSF is retrieved
measure: Backache first 8 days after the lumbar puncture (LP)
timeFrame: Assessed at 8 days after the LP
measure: Severity of backache first 8 days after the LP
timeFrame: Assessed at 8 days after the LP
measure: Severity of backache first 15 days after the LP
timeFrame: Assessed at 15 days after the LP
measure: Backache first 15 days after the LP
timeFrame: Assessed at 15 days after the LP
measure: Post-lumbar puncture headache (PLPH) at 8 days
timeFrame: 8 days after the LP
measure: Post-lumbar puncture headache (PLPH) at 15 days
timeFrame: 15 days after the LP
measure: Severity of the post-lumbar puncture headache (PLPH) at 8 days
timeFrame: 8 days after the LP
measure: Severity of the post-lumbar puncture headache (PLPH) at 15 days
timeFrame: 15 days after the LP
measure: Time to get CSF
timeFrame: During the LP
measure: Extra time patients are willing to spend - part 1
timeFrame: immediately after the LP
measure: Extra time patients are willing to spend - part 2
timeFrame: 8 days after LP
measure: Extra time patients willing to spend - part 3
timeFrame: 15 days after LP
measure: Pain related to LP
timeFrame: Immediately after LP
measure: Number of attempts
timeFrame: during the LP
measure: Medical attention for PLPH
timeFrame: at 15 days
measure: Medical attention for backache
timeFrame: at 8 days
measure: Medical attention for backache
timeFrame: at 15 days
measure: Medical treatment for PLPH
timeFrame: 8 days
measure: Medical treatment for PLPH
timeFrame: 15 days
measure: Medical treatment for backache
timeFrame: 8 days
measure: Medical treatment for backache
timeFrame: 15 days
measure: Epidural blood patch for PLPH
timeFrame: at 8 days
measure: Epidural blood patch for PLPH
timeFrame: at 15 days
measure: Undifferentiated headache at 8 days
timeFrame: 8 days after the LP
measure: Undifferentiated headache at 15 days
timeFrame: 15 days after the LP
measure: Hearing loss
timeFrame: 8 days after LP
measure: Hearing loss
timeFrame: 15 days after LP
measure: Time to collect 14 ml of CSF
timeFrame: after 14 ml of CSF is retrieved
measure: Medical attention for PLPH
timeFrame: at 8 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Neurological Hospital and Institute
state: Quebec
Study officials:
affiliation: Montreal Neurological Hospital and Institute, McGill University
name: Liam Durcan, MD, FRCP(c)
role: PRINCIPAL_INVESTIGATOR
References:
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 [RETIRED]: 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.
citation: 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.
citation: 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.