NCT05031936

Brief Summary

The purpose of this study is to compare using Toughy needle has an advantage of reducing intravascular injection rates during cervical medial branch block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

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

August 12, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

August 19, 2021

Last Update Submit

December 18, 2022

Conditions

Vascular Complications

Keywords

intravascular injection

Outcome Measures

Primary Outcomes (1)

  • incidence of intravascular injection

    incidence of intravascular injection during cervical medial branch block

    1 minute after finishing cervical medial branch block

Secondary Outcomes (2)

  • time required to complete cervical medial branch block

    Baseline, 1 second after the completion of cervical medial branch block

  • radiation amout to complete cervical medial branch block

    Baseline, 1 second after the completion of cervical medial branch block

Study Arms (2)

Touhy needle group

ACTIVE COMPARATOR

cervical medial branch block using touhy needle

Procedure: cervical spinal injection with 0.2% ropivacaine

Quincke needle group

PLACEBO COMPARATOR

cervical medial branch block using quincke needle

Procedure: cervical spinal injection with 0.2% ropivacaine

Interventions

cervical spinal injection with 0.2% ropivacainePROCEDURE

spinal injections performed in cervical pillar area to relieve chronic neck pain

Quincke needle groupTouhy needle group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • facet joint arthropathy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong ji HEE

Daegu, 42601, South Korea

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ji Hee Hong

    Keimyung University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 19, 2021

First Posted

September 2, 2021

Study Start

August 12, 2021

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

December 20, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)