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CompletedNCT03308136Updated Jan 11, 2019

The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections

An interventional study of 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer. and 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway. in Lumbar Radiculopathy Due to Spinal Nerve Compression, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-11.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain. But needle handling during the procedure may cause pain and discomfort to the patient. At the local skin anesthesia step, local anesthetics injection to the muscle layer along the needle pathway as well as the subcutaneous layer may reduce the procedural pain. In addition, it can reduce the injection site pain that may occur after the procedure.

Read the detailed description
  1. A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.
  2. This study is single-blind because it is not possible to blind the practitioner performing the injection.
  3. Subjects were randomly assigned to the subcutaneous anesthesia group (group A) and the muscle anesthesia group (group B) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
  4. After the procedure, a resident who does not know of this study records the patient's pain and discomfort. and on follow-up visits, post injection site pain is checked.
  5. Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner
02

Conditions studied

  • Lumbar Radiculopathy Due to Spinal Nerve Compression

Keywords

  • epidural steroid injection
  • procedural pain
  • local Anesthetic Injection
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level.

Exclusion criteria

Exclusion Criteria:

  1. Blood clotting disorder
  2. Infection around the site
  3. Contrast agent allergy
  4. Uncontrolled cardiovascular, cerebrovascular, kidney disease
  5. Past history of spinal surgery (ex, spinal fusion)
  6. If can not block due to Non-cooperation with subjects (ex, if you can not take the stomach)
  7. Patients taking narcotic analgesics
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    subcutaneous anesthesia group (group A)

    Procedure: 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer. · Drug: 1% Lidocaine

  • Active comparator
    muscle anesthesia group (group B)

    Procedure: 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway. · Drug: 1% Lidocaine

Interventions

  • Procedure1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.

    1) In group A, 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.

  • Procedure1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.

    2) In group B, 1ml of a local anesthetics (1% Lidocaine) are first injected into the subcutaneous layer, followed by 3\~4ml of local anesthetics to the muscle layer along the expected needle pathway.

  • Drug1% Lidocaine

    1% Lidocaine

05

What researchers measure

Primary outcomes

  1. Procedural Pain score (NRS)

    Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable)

    Time frame: Immediately after the procedure

Secondary outcomes

  1. At the next outpatient visit, whether the injection site pain(Yes) or not(No)

    At the next outpatient visit, subjects asked about injection site pain (Yes / No) after the last injection.

    Time frame: 2 weeks

06

Study locations

1 site
  • Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,
    Seoul, 03722, Korea, Republic of
07

References and documents

Publications

  • Baek IC, Choi SY, Suh J, Kim SH. The Influence of Local Anesthesia Depth on Procedural Pain During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2019 Apr;98(4):253-257. doi: 10.1097/PHM.0000000000001032. PubMed 30153126 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03308136
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Oct 12, 2017
Start date
Oct 16, 2017
Primary completion
Feb 28, 2018
Completion
Feb 28, 2018
Last update
Jan 11, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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