NCT05956054

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2024

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

July 13, 2023

Last Update Submit

July 13, 2023

Conditions

S1 Transforaminal Epidural Injection

Keywords

S1 transforaminal epidural injectioncurved needle

Outcome Measures

Primary Outcomes (1)

  • Intravasation rate

    in the procedure

Study Arms (2)

S1 transforaminal injection with a straight needle

ACTIVE COMPARATOR
Other: needle type

S1 transforaminal injection with a curved needle

EXPERIMENTAL
Other: needle type

Interventions

needle typeOTHER

straight or curved

S1 transforaminal injection with a curved needleS1 transforaminal injection with a straight needle

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 41944, South Korea

RECRUITING

Central Study Contacts

Jinyoung Oh, MD, PHD

CONTACT

+82-010-4425-0304sgcms3@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

June 22, 2023

Primary Completion

April 2, 2024

Study Completion

April 2, 2024

Last Updated

July 21, 2023

Record last verified: 2023-07

Locations

KR(1)