Intravascular Injection Incidences During Lumbar Medial Branch Block

May 19, 2022 updated by: Ji Hee Hong, Keimyung University Dongsan Medical Center

Comparison of Intravascular Injection Incidences Durig Lumbar Medial Branch Block Using Anteroposterior or Oblique Angle

The purpose of this study is to compare using oblique fluoroscopic angle has any advantage in reducing the incidence of vascular punture and technical easiness during lumbar medial branch block

Study Overview

Status

Completed

Detailed Description

In previous report, the use of oblique fluoroscopic angle during S1 transforaminal injection demonstrated technical easiness and reduced intravascular injection incidences. For the procedure lumbar medial branch block, both anteroposterior and oblique fluoroscopic angle are possible. Usually, which approach method to use is determined according to the physician's preferences.

The final target for lumbar medial branch block is the junction betweeen superior articular process and transverse process. This target can be easily confirmed under the scotty dog appearance. If we use oblique fluoroscopic angle, this approach (30 degree) can make scotty dog appearance more visible so that physician can identify bony landmark more easily for lumbar medial branch block. For beginners, oblique fluoroscopic approach seems to provide more advantages in identifying bony landmark. However, it is uncertain whether this approach can provide technicaL easiness and reduce the intravascualr injection incidences.

Study Type

Interventional

Enrollment (Actual)

32

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

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 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • facet joint arthropathy

Exclusion Criteria:

  • allergy to local anesthetics or contrast medium
  • pregnancy
  • spine deformity
  • neurologic abnormality

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oblique group
medial branch block with oblique group
lumbar medial branch block
Placebo Comparator: Anteroposterior group
medial branch block with anteroposterior group
lumbar medial branch block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of intravasuclar injection
Time Frame: 1 minute after finishing lumbar medial branch block
incidence of intravasuclar injection
1 minute after finishing lumbar medial branch block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time required to complete lumbar medial branch block
Time Frame: 1 second after finishing lumbar medial branch block
time required to complete lumbar medial branch block
1 second after finishing lumbar medial branch block
radiation amount to complete lumbar medial branch block
Time Frame: 1 second after finishing lumbar medial branch block
radiation amount to complete lumbar medial branch block
1 second after finishing lumbar medial branch block

Collaborators and Investigators

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

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)

September 3, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-07-014-002

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.

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