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Completed

NCT Number: NCT03308136

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

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.

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Key information

Conditions

Lumbar Radiculopathy Due to Spinal Nerve Compression Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,

Seoul, 03722, South Korea

About this study

  • A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.
  • This study is single-blind because it is not possible to blind the practitioner performing the injection.
  • 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.
  • 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.
  • Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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

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

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.

Procedure
  • 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.

1% Lidocaine

Drug

1% Lidocaine

Primary outcomes

  1. Procedural Pain score (NRS)

    Time frame: Immediately after the procedure

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

Secondary outcomes

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

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2017
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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