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

McGill University logo

McGill University

Status and phase

Completed
Phase 4

Conditions

Post-lumbar Puncture Headache
Backache

Treatments

Device: whitacre 24 gauge
Device: whitacre 22 gauge

Study type

Interventional

Funder types

Other

Identifiers

NCT01481922
NEU-11-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

62 participants in 2 patient groups

Whitacre 22 gauge
Active Comparator group
Description:
lumbar puncture performed with a Whitacre 22 gauge (BD)
Treatment:
Device: whitacre 22 gauge
Whitacre 24 gauge
Experimental group
Description:
lumbar puncture performed with a Whitacre 24 gauge (BD)
Treatment:
Device: whitacre 24 gauge

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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