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.

Status Recruiting

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.

Clinical Trial 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 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

• NCT number: NCT01481922
• Study type: Interventional
• Source: McGill University
• Contact: Matthieu Vincent, MD, CCFP(EM)
• Phone: 450-651-8287
• Email: matthieu_vincent@hotmail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2011
• Completion date: May 2013