Post-lumbar Puncture HeadachePhase 4NCT01481922
What Needle Diameter Should Physician Use When They Perform Lumbar Puncture ? A Randomized Controlled Trial
A Phase 4 study testing whitacre 24 gauge and whitacre 22 gauge in people with Post-lumbar Puncture Headache and Backache, run by McGill University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-lumbar Puncture Headache, Backache
- What is being tested?
- whitacre 24 gauge and whitacre 22 gauge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (>= 18 years old) referred at the Neurological Day Center to get a lumbar puncture
Who cannot join
- Contraindication to get a lumbar puncture
Trial locations and contacts
1 site in 1 country.
Canada1 site
Montreal Neurological Hospital and Institute
Montreal, Quebec, H3A 2B4
About this study
Official title: Should Physicians Use a 24 Gauge Spinal Needle Instead of a 22 Gauge When Performing a Lumbar Puncture ? A Randomized Controlled Trial.
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.
Read more
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.
Read the 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.
- Conditions
- Post-lumbar Puncture Headache, Backache
- Being tested
- whitacre 24 gauge, whitacre 22 gauge
- Keywords
- Lumbar puncture, Flow rate, Backache, Pain, Undifferentiated headache, Post-lumbar puncture headache
- Medical subject headings
- Post-Dural Puncture Headache, Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whitacre 24 gaugeDevice
Also called Product number: 405133
Whitacre 24 gauge spinal needle 3 inches 1/2. Manufactured by Becton Dickinson
whitacre 22 gaugeDevice
Also called product number 405010
Whitacre 22 gauge spinal needle 3 inches 1/2 manufactured by Becton Dickinson
| Study group | Role | What they receive |
|---|---|---|
| Whitacre 22 gauge | Active comparator | lumbar puncture performed with a Whitacre 22 gauge (BD) Receives: Device: whitacre 22 gauge |
| Whitacre 24 gauge | Experimental | lumbar puncture performed with a Whitacre 24 gauge (BD) Receives: Device: whitacre 24 gauge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 5 ml of CSF is retrieved
Secondary outcomes (38)
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.
Measured: after 7 ml of CSF is retrieved
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.
Measured: after 8 ml of CSF is retrieved
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.
Measured: after 9 ml of CSF is retrieved
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.
Measured: after 10 ml of CSF is retrieved
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.
Measured: after 6 ml of CSF is retrieved
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.
Measured: after 11 ml of CSF is retrieved
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.
Measured: after 12 ml of CSF is retrieved
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.
Measured: after 13 ml of CSF is retrieved
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.
Measured: after 15 ml of CSF is retrieved
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.
Measured: Assessed at 8 days after the LP
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)
Measured: Assessed at 8 days after the LP
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)
Measured: Assessed at 15 days after the LP
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.
Measured: Assessed at 15 days after the LP
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.
Measured: 8 days after the LP
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.
Measured: 15 days after the LP
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.
Measured: 8 days after the LP
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.
Measured: 15 days after the LP
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
Measured: During the LP
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
Measured: immediately after the LP
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
Measured: 8 days after LP
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
Measured: 15 days after LP
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)
Measured: Immediately after LP
Number of attempts
The number of attempts before collection of CSF is successful will be recorded
Measured: during the LP
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.
Measured: at 15 days
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.
Measured: at 8 days
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.
Measured: at 15 days
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).
Measured: 8 days
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)
Measured: 15 days
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)
Measured: 8 days
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)
Measured: 15 days
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.
Measured: at 8 days
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.
Measured: at 15 days
Undifferentiated headache at 8 days
The presence of any headache since the LP will be assessed by phone call by a blinded research assistant.
Measured: 8 days after the LP
Undifferentiated headache at 15 days
The presence of any headache since the LP will be assessed by phone call by a blinded research assistant.
Measured: 15 days after the LP
Hearing loss
The presence of subjective hearing loss will be recorded at 8 days by a phone call by a blinded research assistant
Measured: 8 days after LP
Hearing loss
The presence of subjective hearing loss will be recorded at 8 days by a phone call by a blinded research assistant
Measured: 15 days after LP
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.
Measured: after 14 ml of CSF is retrieved
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.
Measured: at 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-lumbar Puncture HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- funding: McGill Emergency Medicine 2010 Grant Competition
- Responsible party
- Principal investigator, Liam Durcan, McGill University
- Investigators
- Liam Durcan, MD, FRCP(c), Principal investigator, Montreal Neurological Hospital and Institute, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481922
- Sponsor's protocol ID
- NEU-11-001
- Status last verified
- Mar 2016
- First submitted
- 15 Nov 2011
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16116106Abouleish 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.
PubMed 8148292Carson 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.
PubMed 8710120
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Physicians Use a 24 Gauge Spinal Needle Instead of a 22 Gauge When Performing a Lumbar Puncture ? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01481922
- Acronym / sponsor ID
- NEU-11-001
- Conditions
- Post-lumbar Puncture Headache, Backache
- Keywords
- Lumbar puncture, Flow rate, Backache, Pain, Undifferentiated headache, Post-lumbar puncture headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- funding: McGill Emergency Medicine 2010 Grant Competition
- Study start
- Nov 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whitacre 22 gauge | Active comparator | Device: whitacre 22 gaugelumbar puncture performed with a Whitacre 22 gauge (BD) |
| Whitacre 24 gauge | Experimental | Device: whitacre 24 gaugelumbar puncture performed with a Whitacre 24 gauge (BD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (>= 18 years old) referred at the Neurological Day Center to get a lumbar puncture
Key exclusion criteria (1 listed)
- Contraindication to get a lumbar puncture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whitacre 24 gaugeAlso: Product number: 405133Whitacre 24 gauge spinal needle 3 inches 1/2. Manufactured by Becton Dickinson | Device | Whitacre 24 gauge |
| whitacre 22 gaugeAlso: product number 405010Whitacre 22 gauge spinal needle 3 inches 1/2 manufactured by Becton Dickinson | Device | Whitacre 22 gauge |
Primary outcome
Time to collect 5 ml of CSF
Time frame: after 5 ml of CSF is retrieved
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.
38 secondary outcomes
Time to collect 7 ml of CSF
Time frame: after 7 ml of CSF is retrieved
Time to collect 8 ml of CSF
Time frame: after 8 ml of CSF is retrieved
Time to collect 9 ml of CSF
Time frame: after 9 ml of CSF is retrieved
Time to collect 10 ml of CSF
Time frame: after 10 ml of CSF is retrieved
Time to collect 6 ml of CSF
Time frame: after 6 ml of CSF is retrieved
Time to collect 11 ml of CSF
Time frame: after 11 ml of CSF is retrieved
Time to collect 12 ml of CSF
Time frame: after 12 ml of CSF is retrieved
Time to collect 13 ml of CSF
Time frame: after 13 ml of CSF is retrieved
Time to collect 15 ml of CSF
Time frame: after 15 ml of CSF is retrieved
Backache first 8 days after the lumbar puncture (LP)
Time frame: Assessed at 8 days after the LP
Severity of backache first 8 days after the LP
Time frame: Assessed at 8 days after the LP
Severity of backache first 15 days after the LP
Time frame: Assessed at 15 days after the LP
Backache first 15 days after the LP
Time frame: Assessed at 15 days after the LP
Post-lumbar puncture headache (PLPH) at 8 days
Time frame: 8 days after the LP
Post-lumbar puncture headache (PLPH) at 15 days
Time frame: 15 days after the LP
Severity of the post-lumbar puncture headache (PLPH) at 8 days
Time frame: 8 days after the LP
Severity of the post-lumbar puncture headache (PLPH) at 15 days
Time frame: 15 days after the LP
Time to get CSF
Time frame: During the LP
Extra time patients are willing to spend - part 1
Time frame: immediately after the LP
Extra time patients are willing to spend - part 2
Time frame: 8 days after LP
Extra time patients willing to spend - part 3
Time frame: 15 days after LP
Pain related to LP
Time frame: Immediately after LP
Number of attempts
Time frame: during the LP
Medical attention for PLPH
Time frame: at 15 days
Medical attention for backache
Time frame: at 8 days
Medical attention for backache
Time frame: at 15 days
Medical treatment for PLPH
Time frame: 8 days
Medical treatment for PLPH
Time frame: 15 days
Medical treatment for backache
Time frame: 8 days
Medical treatment for backache
Time frame: 15 days
Epidural blood patch for PLPH
Time frame: at 8 days
Epidural blood patch for PLPH
Time frame: at 15 days
Undifferentiated headache at 8 days
Time frame: 8 days after the LP
Undifferentiated headache at 15 days
Time frame: 15 days after the LP
Hearing loss
Time frame: 8 days after LP
Hearing loss
Time frame: 15 days after LP
Time to collect 14 ml of CSF
Time frame: after 14 ml of CSF is retrieved
Medical attention for PLPH
Time frame: at 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Background: PubMed 16116106Armon 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.
- Background: PubMed 8148292Abouleish 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.
- Background: PubMed 8710120Carson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liam Durcan, MD, FRCP(c) principal investigator
Montreal Neurological Hospital and Institute, McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing whitacre 24 gauge and whitacre 22 gauge in people with Post-lumbar Puncture Headache and Backache, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to collect 5 ml of CSF (time frame: after 5 ml of CSF is retrieved). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481922, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016; AzTrials last refreshed its copy on 31 Oct 2026.