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

January 10, 2019 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: subcutaneous anesthesia group (group A)
Procedure: 1ml 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.
Drug: 1% Lidocaine
1% Lidocaine
ACTIVE_COMPARATOR: muscle anesthesia group (group B)
Drug: 1% Lidocaine
1% Lidocaine
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural Pain score (NRS)
Time Frame: Immediately after the procedure
Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable)
Immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 16, 2017

Primary Completion (ACTUAL)

February 28, 2018

Study Completion (ACTUAL)

February 28, 2018

Study Registration Dates

First Submitted

September 20, 2017

First Submitted That Met QC Criteria

October 11, 2017

First Posted (ACTUAL)

October 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-0683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar Radiculopathy Due to Spinal Nerve Compression

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe