A Comparison of Intravascular Penetration With Curved Needle and Straight Needle During S1 STE

July 13, 2023 updated by: Jinyoung Oh, Kyungpook National University Chilgok Hospital

A Comparison of Intravascular Penetration With Curved Needle and Straight Needle During Sacral 1 Transforaminal Epidural Block

The goal of this observational study is to compare in intravasation rate during S1 transforaminal epidural injection between using a straight needle and a curved needle. The main question it aims to answer are:

The main question it aims to answer is:

• whether there is a difference in intravascular rate between using a straight needle and a curved needle in S1 transforaminal epidural injection

Participants in this study will be randomly assigned to receive an S1 transforaminal epidural injection using either a straight needle or a curved needle. The researchers will then observe the intravasation rate and compare it between the two groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

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 Contact

  • Name: Jinyoung Oh, MD, PHD
  • Phone Number: +82-010-4425-0304
  • Email: sgcms3@gmail.com

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 41944
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
          • Jinyoung Oh, MD, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients scheduled for a lumbar 1 epidural nerve block in the outpatient department of anesthesiology and pain medicine at Kyungpook National University Hospital.

Exclusion Criteria:

  1. Patients with a history of allergy to local anesthetics or steroids
  2. Patients with a history of allergy to contrast media
  3. Patients with a bleeding tendency
  4. Patients with symptoms of infection in the sacroiliac region
  5. Patients under 18 years of age or over 80 years of age
  6. Patients who are pregnant or planning to become pregnant
  7. Other medically incapable of consent, such as the mentally retarded.

Translated with www.DeepL.com/Translator (free version)

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: S1 transforaminal injection with a straight needle
Other: needle type
straight or curved
Experimental: S1 transforaminal injection with a curved needle
Other: needle type
straight or curved

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intravasation rate
Time Frame: in the procedure
in the procedure

Collaborators and Investigators

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

Sponsor

Kyungpook National University Chilgok Hospital

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)

June 22, 2023

Primary Completion (Estimated)

April 2, 2024

Study Completion (Estimated)

April 2, 2024

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-04-018-001

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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