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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
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 14, 2017
    Last Updated
    September 15, 2017
    Sponsor
    Kyungpook National University Hospital
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    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

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