Detection of Intravascular Injection Between Blunt and Sharp Needles During Cervical Transforaminal Epidural Block.
Primary Purpose
Pain, Radicular; Neuropathic, Cervical
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
block with Blunt-type block needle.
block with sharp-type block needle.
Sponsored by
About this trial
This is an interventional screening trial for Pain
Eligibility Criteria
Inclusion Criteria:
- Patients with radiating pain from cervical spinal stenosis and herniated nucleus pulposus.
Exclusion Criteria:
- Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Blunt-type block needle
Sharp-type block needle
Arm Description
block with Blunt-type block needle.
block with Sharp-type block needle.
Outcomes
Primary Outcome Measures
Intravascular injection
Intravascular injection was defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy. The investigators observed the intravascular injection during the procedure. The intravascular injection rate was calculated based on the total number of treated levels.
Secondary Outcome Measures
Needling time
Needling time for both the sharp and blunt needles was started upon insertion of the needle through the skin and ended upon injection of contrast media under real time fluoroscopy.
Full Information
NCT ID
NCT03286946
First Posted
September 14, 2017
Last Updated
September 15, 2017
Sponsor
Kyungpook National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03286946
Brief Title
Detection of Intravascular Injection Between Blunt and Sharp Needles During Cervical Transforaminal Epidural Block.
Official Title
The Difference of Intravascular Injection Rate During Cervical Transforaminal Epidural Block Using Blunt-type Block Needle Compared to Sharp-type Block Needle.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 20, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluates the incidence of intravascular injection during cervical transforaminal epidural block using blunt needle, compared to the sharp needle. The investigators will performed cervical transforaminal epidural block using blunt-type block needle in half of participants or sharp-type block needle in the other half.
Detailed Description
Cervical transforaminal epidural block is an effective treatment option of radiating pain. There are potential risks associated with transforaminal epidural block such as infection, dural puncture, bleeding, and intravascular injection. Although the risk is low, intravascular injection should be carefully monitored because intravascular injection of particulate steroids can cause fatal neurologic deficits such as spinal infarction and cerebral infarction.
The incidence of intravascular injection during transforaminal epidural block with real time fluoroscopy guidance depends on spinal level. The previous studies using real time fluoroscopy demonstrated that the incidence of intravascular injection of cervical transforaminal epidural block is higher than that of lumbosacral transforaminal epidural block.
In this study, therefore, the investigators investigate the incidence of intravascular injection during cervical transforaminal epidural block using blunt needle, compared to the sharp needle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Radicular; Neuropathic, Cervical
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blunt-type block needle
Arm Type
Experimental
Arm Description
block with Blunt-type block needle.
Arm Title
Sharp-type block needle
Arm Type
Active Comparator
Arm Description
block with Sharp-type block needle.
Intervention Type
Procedure
Intervention Name(s)
block with Blunt-type block needle.
Intervention Description
Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge blunt needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.
Intervention Type
Procedure
Intervention Name(s)
block with sharp-type block needle.
Intervention Description
Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge sharp needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.
Primary Outcome Measure Information:
Title
Intravascular injection
Description
Intravascular injection was defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy. The investigators observed the intravascular injection during the procedure. The intravascular injection rate was calculated based on the total number of treated levels.
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Needling time
Description
Needling time for both the sharp and blunt needles was started upon insertion of the needle through the skin and ended upon injection of contrast media under real time fluoroscopy.
Time Frame
During procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with radiating pain from cervical spinal stenosis and herniated nucleus pulposus.
Exclusion Criteria:
Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
12. IPD Sharing Statement
Learn more about this trial
Detection of Intravascular Injection Between Blunt and Sharp Needles During Cervical Transforaminal Epidural Block.
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