A Comparison of Intravascular Penetration With Curved Nee... | NCT05956054

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

NCT05956054

Sponsor

Kyungpook National University Chilgok Hospital

Status

Unknown status

Last Update Posted

Jul 21, 2023Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

S1 Transforaminal Epidural Injection

Interventions

needle type

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2023Actual

Primary Completion Date

Apr 2, 2024Estimated

Completion Date

Apr 2, 2024Estimated

First Submitted Date

Jul 13, 2023

First Submission Date that Met QC Criteria

Jul 13, 2023

First Posted Date

Jul 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2023

Last Update Posted Date

Jul 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jinyoung Oh, assistant professor, Kyungpook National University Chilgok HospitalPrincipal Investigator

Lead Sponsor

Kyungpook National University Chilgok HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
S1 transforaminal injection with a straight needle	Active Comparator		Other: needle type
S1 transforaminal injection with a curved needle	Experimental		Other: needle type

Interventions

Name	Type	Description	Arm Group Labels	Other Names
needle type	Other	straight or curved	S1 transforaminal injection with a curved needle S1 transforaminal injection with a straight needle

Measure	Description	Time Frame
Intravasation rate		in the procedure

Eligibility Module

Eligibility Criteria

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:

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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinyoung Oh, MD, PHD	Contact	+82-010-4425-0304		sgcms3@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyungpook National University Hospital	Recruiting	Daegu		41944	South Korea