NCT04774458

Brief Summary

The aim of the present study is to investigate the safety and clinical utility of contralateral oblique view for fluoroscopic guided cervical epidural access.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
439

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 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

First Submitted

Initial submission to the registry

February 21, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

February 21, 2021

Last Update Submit

September 6, 2022

Conditions

Cervical Intervertebral Disc DiseaseCervical Spinal StenosisCervical Radicular PainHerpes ZosterPostherpetic Neuralgia

Keywords

fluoroscopycontralateral oblique viewcervical epidural blockcervical epidural space

Outcome Measures

Primary Outcomes (1)

  • Dural puncture event - major complication

    whether a dural puncture event occurs or not during the cervical epidural access

    Immediately after contrast medium administration during the procedure

Secondary Outcomes (12)

  • Other complications

    Immediately after procedure

  • Needling time

    Immediately after procedure

  • First attempt success

    Immediately after procedure

  • Total number of needle passes

    Immediately after procedure

  • Rate of success or failure

    Immediately after procedure

  • +7 more secondary outcomes

Study Arms (1)

Fluoroscopic-guided cervical epidural access

EXPERIMENTAL

Cervical epidural access with loss of resistance technique using CLO view at 50 degree under fluoroscopic guidance.

Procedure: Fluoroscopic-guided cervical epidural access

Interventions

Fluoroscopic-guided cervical epidural accessPROCEDURE

After identifying the target level of the cervical spine under a fluoroscopy-guided anteroposterior image, an 18-Tuohy needle is inserted through a paramedian approach after local infiltration with 1% lidocaine. When feeling a strong resistance through the needle by a ligamentum flavum, the image intensifier is rotated to 50 degrees contralateral oblique (CLO) direction. After then, the needle is advanced to just before the ventral interlaminar line in CLO view. It is subsequently advanced further until it is in the epidural space using a LOR-to-air technique. Correct epidural access is confirmed by the injection of contrast medium. After identifying epidural space in AP and CLO view without abnormal dispersion of contrast,(vascular uptake, intrathecal spreads, etc.), a 3-4ml mixture of 0.5% lidocaine with dexamethasone 5mg is injected.

Fluoroscopic-guided cervical epidural access

Eligibility Criteria

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

You may qualify if:

  • Patients who need an epidural space access at C6-7 or C7-T1 level
  • Patients who are expected to undergo cervical epidural block
  • Patients who are expected to undergo cervical epidural neuroplasty
  • ≤ age \<80
  • When obtaining informed consent voluntarily

You may not qualify if:

  • Allergy to local anesthetics and contrast dye, and steroid
  • Use of anticoagulants or antiplatelet medication, coagulopathy
  • Infection at the insertion site
  • Neurological or psychiatric disorders
  • Prior spine instrumentation
  • Pregnancy
  • Not visible epidural space due to severe cervical spinal canal stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan medical center

Seoul, 05505, South Korea

Location

Related Publications (1)

  • Kwon HJ, Kim CS, Kim J, Kim S, Shin JY, Choi SS, Shin JW, Kim DH. Contralateral oblique view can prevent dural puncture in fluoroscopy-guided cervical epidural access: a prospective observational study. Reg Anesth Pain Med. 2023 Dec;48(12):588-593. doi: 10.1136/rapm-2022-104297. Epub 2023 Apr 6.

    PMID: 37024268DERIVED

MeSH Terms

Conditions

Herpes ZosterNeuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Doo-Hwan Kim, MD, PhD

    Assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 21, 2021

First Posted

March 1, 2021

Study Start

March 4, 2021

Primary Completion

July 28, 2022

Study Completion

August 31, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations

KR(1)