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

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ClinicalTrials.gov Identifier: NCT04350307
Recruitment Status : Completed
First Posted : April 17, 2020
Results First Posted : July 20, 2020
Last Update Posted : July 20, 2020
Sponsor:
Collaborator:
Rothman Institute Orthopaedics
Information provided by (Responsible Party):
Robin Raju, DO, Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Needle Injury Device: 22-gauge needle Device: 25-gauge needle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This was a prospective single blind randomized clinical trial.
Masking: Single (Participant)
Masking Description: Randomization was done separately for each provider based on a computer generated algorithm. Patients were blinded to the gauge of the needle used for the procedure.
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : September 30, 2019

Arm Intervention/treatment
Active Comparator: 22-Gauge Arm
Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle
Device: 22-gauge needle
22-gauge Quincke needle used for epidural injection

Device: 25-gauge needle
25-gauge Quincke needle used for epidural injection

Active Comparator: 25-Gauge Arm
Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle
Device: 22-gauge needle
22-gauge Quincke needle used for epidural injection

Device: 25-gauge needle
25-gauge Quincke needle used for epidural injection




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Patient Reported Pain [ Time Frame: During the procedure ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350307


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Rothman Institute Orthopaedics
Investigators
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Principal Investigator: Robin Raju, DO Yale University
  Study Documents (Full-Text)

Documents provided by Robin Raju, DO, Yale University:
Informed Consent Form  [PDF] August 22, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robin Raju, DO, Clinical Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT04350307    
Other Study ID Numbers: 2000023982
First Posted: April 17, 2020    Key Record Dates
Results First Posted: July 20, 2020
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes