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

Yale University logo

Yale University

Status

Completed

Conditions

Needle Injury
Pain

Treatments

Device: 22-gauge needle
Device: 25-gauge needle

Study type

Interventional

Funder types

Other

Identifiers

NCT04350307
2000023982

Details and patient eligibility

About

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.

Full 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.

Enrollment

162 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

162 participants in 2 patient groups

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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