PainNCT04350307

Comparison of Intravascular Uptake and Pain Perception During Epidural Injection Using 22 Gauge vs 25 Gauge Needle

A study testing 22-gauge needle and 25-gauge needle in people with Pain and Needle Injury, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral epidural steroid injection in regards to intravascular uptake and pain perception. There is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Needle Injury
What is being tested?: 22-gauge needle and 25-gauge needle
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2018to 30 Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

patients with low back pain and/or radicular pain,
patients scheduled for lumbosacral TFESI.

Who cannot join

patients with contrast/local anesthetic allergy,
patients with pregnancy, coagulopathy, systemic infection, and inability to provide informed consent,
vulnerable patient population including prisoners,
patients with severe anxiety,
patients with prior lumbar surgery,
age <18 years old, and
Body Mass Index (BMI) > 40.

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: Differential Rates of Intravascular Uptake and Pain Perception During Lumbosacral Transforaminal Epidural Steroid Injection Using a 22-gauge Needle Versus 25-gauge Needle

Read the detailed description

Inadvertent intravascular injection has been suggested as the most probable mechanism behind serious neurological complications during transforaminal epidural steroid injections. There is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain. The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injection in regards to intravascular uptake and pain perception.

Conditions: Pain, Needle Injury
Being tested: 22-gauge needle, 25-gauge needle
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

22-gauge needleDevice
22-gauge Quincke needle used for epidural injection
25-gauge needleDevice
25-gauge Quincke needle used for epidural injection

Study groups in NCT04350307
Study group	Role	What they receive
22-Gauge Arm	Active comparator	Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle Receives: Device: 22-gauge needle; Device: 25-gauge needle
25-Gauge Arm	Active comparator	Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle Receives: Device: 22-gauge needle; Device: 25-gauge needle

What is being measured

The primary outcome is the main question the study is designed to answer.

Intravascular Uptake
The intravascular uptake percentage reported in the study is the percent of 'needles' that showed intravascular uptake. Hence higher 'intravascular uptake percentage' means worse outcome. The mean percentages were averaged across participants were compared between treatment arms.
Presence or absence of intravascular uptake during live fluoroscopy and/or blood aspiration per needle. Once needle reached its target (epidural space), contrast was injected to confirm the presence or absence of intravascular uptake via live fluoroscopy or aspiration was attempted using a syringe to confirm the presence or absence of intravascular uptake. If contrast pattern suggested needle was in a vessel or blood was aspirated using a syringe, outcome measure was marked 'PRESENT'. If contrast pattern suggested needle was not in a vessel and no blood was aspirated using a syringe, outcome measure was marked 'ABSENT'. In other words, primary outcome measure was binary in nature.
Measured: During the procedure

Secondary outcomes (1)

Patient Reported Pain
Patient reported pain during the procedure (on initial needle entry) on the numerical rating scale (NRS 1-10). Higher numbers implies higher severity of pain. Lower numbers implies lower severity of pain
Measured: During the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201830 Sep 2019

First posted17 Apr 2020
Study start1 Feb 2018
Primary completion30 Jun 2019
Study completion30 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This was a prospective single blind randomized clinical trial.
Masking: Single blind
Who is masked: Participant
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04350307
Sponsor's protocol ID: 2000023982
Status last verified: Jul 2020
First submitted: 10 Apr 2020
Last updated: 20 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Raju R, Mehnert M, Stolzenberg D, Simon J, Conliffe T, Gehret J. Differential rates of intravascular uptake and pain perception during lumbosacral epidural injection among adults using a 22-gauge needle versus 25-gauge needle: a randomized clinical trial. BMC Anesthesiol. 2020 Sep 3;20(1):222. doi: 10.1186/s12871-020-01137-0.
PubMed 32883241

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Differential Rates of Intravascular Uptake and Pain Perception During Lumbosacral Transforaminal Epidural Steroid Injection Using a 22-gauge Needle Versus 25-gauge Needle
ClinicalTrials.gov ID: NCT04350307
Acronym / sponsor ID: 2000023982
Conditions: Pain, Needle Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Rothman Institute Orthopaedics
Study start: 1 Feb 2018 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 30 Sep 2019 (actual)
First posted: 17 Apr 2020 (actual)
Results: Posted 20 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This was a prospective single blind randomized clinical trial.

Arm	Type	Receives
22-Gauge Arm	Active comparator	Device: 22-gauge needle, Device: 25-gauge needlePatient undergoing epidural injection in this arm will get 22-gauge Quincke needle
25-Gauge Arm	Active comparator	Device: 22-gauge needle, Device: 25-gauge needlePatient undergoing epidural injection in this arm will get 25-gauge Quincke needle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

patients with low back pain and/or radicular pain,
patients scheduled for lumbosacral TFESI.

Key exclusion criteria (7 listed)

patients with contrast/local anesthetic allergy,
patients with pregnancy, coagulopathy, systemic infection, and inability to provide informed consent,
vulnerable patient population including prisoners,
patients with severe anxiety,
patients with prior lumbar surgery,

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
22-gauge needle22-gauge Quincke needle used for epidural injection	Device	22-Gauge Arm, 25-Gauge Arm
25-gauge needle25-gauge Quincke needle used for epidural injection	Device	22-Gauge Arm, 25-Gauge Arm

Primary outcome

Intravascular Uptake
Time frame: During the procedure
The intravascular uptake percentage reported in the study is the percent of 'needles' that showed intravascular uptake. Hence higher 'intravascular uptake percentage' means worse outcome. The mean percentages were averaged across participants were compared between treatment arms. Presence or absence of intravascular uptake during live fluoroscopy and/or blood aspiration per needle. Once needle reached its target (epidural space), contrast was injected to confirm the presence or absence of intravascular uptake via live fluoroscopy or aspiration was attempted using a syringe to confirm the presence or absence of intravascular uptake. If contrast pattern suggested needle was in a vessel or blood was aspirated using a syringe, outcome measure was marked 'PRESENT'. If contrast pattern suggested needle was not in a vessel and no blood was aspirated using a syringe, outcome measure was marked 'ABSENT'. In other words, primary outcome measure was binary in nature.

1 secondary outcome

Patient Reported Pain
Time frame: During the procedure

Results and safety

Results posted to the registry on 20 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
22-Gauge Arm	84	84
25-Gauge Arm	78	78

Primary outcome: Intravascular Uptake

Time frame: During the procedure. Mean (95% Confidence Interval). Unit: percentage of total number of needle

Measure	22-Gauge Arm n = 84	25-Gauge Arm n = 78
Value	5.9 (1.9 to 9.8)	7.1 (2.4 to 11.8)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Each participant was assessed for adverse events within 1 month after the injection date.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
22-Gauge Arm	0 of 84 (0%)	0 of 84 (0%)	0 of 84
25-Gauge Arm	0 of 78 (0%)	0 of 78 (0%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32883241Raju R, Mehnert M, Stolzenberg D, Simon J, Conliffe T, Gehret J. Differential rates of intravascular uptake and pain perception during lumbosacral epidural injection among adults using a 22-gauge needle versus 25-gauge needle: a randomized clinical trial. BMC Anesthesiol. 2020 Sep 3;20(1):222. doi: 10.1186/s12871-020-01137-0.
Individual participant dataSharing planned: No

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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.

Robin Raju, DO principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 22-gauge needle and 25-gauge needle in people with Pain and Needle Injury, run by Yale University at 1 site in United States.

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 2 inclusion and 7 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 20 Jul 2020. 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 United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intravascular Uptake (time frame: During the procedure). 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 NCT04350307, which also lists 1 linked publication.

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 20 Jul 2020.