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

NCT01481922 | Completed Phase 4

• 1 other identifier: NEU-11-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-lumbar Puncture Headache; Backache

Keywords

Lumbar puncture; Flow rate; Backache; Pain; Undifferentiated headache; Post-lumbar puncture headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (38)

• Time to collect 7 ml of CSF

  after 7 ml of CSF is retrieved

• Time to collect 8 ml of CSF

  after 8 ml of CSF is retrieved

• Time to collect 9 ml of CSF

  after 9 ml of CSF is retrieved

• Time to collect 10 ml of CSF

  after 10 ml of CSF is retrieved

• Time to collect 6 ml of CSF

  after 6 ml of CSF is retrieved

Study Arms (2)

Whitacre 22 gauge

ACTIVE COMPARATOR

lumbar puncture performed with a Whitacre 22 gauge (BD)

Device: whitacre 22 gauge

Whitacre 24 gauge

EXPERIMENTAL

lumbar puncture performed with a Whitacre 24 gauge (BD)

Device: whitacre 24 gauge

Interventions

whitacre 24 gauge DEVICE

Whitacre 24 gauge spinal needle 3 inches 1/2. Manufactured by Becton Dickinson

Also known as: Product number: 405133

Whitacre 24 gauge

whitacre 22 gauge DEVICE

Whitacre 22 gauge spinal needle 3 inches 1/2 manufactured by Becton Dickinson

Also known as: product number 405010

Whitacre 22 gauge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients (\>= 18 years old) referred at the Neurological Day Center to get a lumbar puncture

You may not qualify if:

• Contraindication to get a lumbar puncture

Sponsors & Collaborators

• McGill University: lead
• funding: McGill Emergency Medicine 2010 Grant Competition: collaborator

Study Sites (1)

Montreal Neurological Hospital and Institute

Montreal, Quebec, H3A 2B4, Canada

Location

Related Publications (3)

• 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.

  PMID: 16116106 BACKGROUND

• 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.

  PMID: 8148292 BACKGROUND

• 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.

  PMID: 8710120 BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache; Back Pain; Pain

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Liam Durcan, MD, FRCP(c)

  Montreal Neurological Hospital and Institute, McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPc, Neurologist-in-Chief, Montreal Neurological Hospital Interim Clinical Director, Neurology, McGill University Health Center

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 30, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

CA (1)