Back to resultsThe Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
Primary Purpose
Lumbar Radiculopathy Due to Spinal Nerve Compression
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
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.
1% Lidocaine
Sponsored by
About this trial
This is an interventional supportive care trial for Lumbar Radiculopathy Due to Spinal Nerve Compression focused on measuring epidural steroid injection, procedural pain, local Anesthetic Injection
Eligibility Criteria
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:
- 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
Sites / Locations
- Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
subcutaneous anesthesia group (group A)
muscle anesthesia group (group B)
Arm Description
Outcomes
Primary Outcome Measures
Procedural Pain score (NRS)
Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03308136
Brief Title
The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
Official Title
The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy Due to Spinal Nerve Compression
Keywords
epidural steroid injection, procedural pain, local Anesthetic Injection
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
subcutaneous anesthesia group (group A) muscle anesthesia group (group B)
Masking
ParticipantInvestigator
Masking Description
The subjects were randomly assigned to subcutaneous anesthesia group (group A) and muscle anesthesia group (group B), and the assigned results are unknown.
The Outcomes Assessor is not related to the study, and does not know its contents.
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subcutaneous anesthesia group (group A)
Arm Type
Experimental
Arm Title
muscle anesthesia group (group B)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.
Intervention Description
1) In group A, 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.
Intervention Type
Procedure
Intervention Name(s)
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.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
1% Lidocaine
Intervention Description
1% Lidocaine
Primary Outcome Measure Information:
Title
Procedural Pain score (NRS)
Description
Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable)
Time Frame
Immediately after the procedure
Secondary Outcome Measure Information:
Title
At the next outpatient visit, whether the injection site pain(Yes) or not(No)
Description
At the next outpatient visit, subjects asked about injection site pain (Yes / No) after the last injection.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Facility Information:
Facility Name
Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30153126
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
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