Evaluation of Drug Spread in Ultrasound-Guided Erector Spina Plane Block With Fluoroscopy
1 other identifier
observational
50
1 country
1
Brief Summary
The purpose of this study is to evaluate the injectate spread in erector spinae plane blocks under fluoroscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedFirst Submitted
Initial submission to the registry
September 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 9, 2021
CompletedNovember 9, 2021
November 1, 2021
3 months
September 28, 2021
November 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The level of contrast spread in the anteroposterior plane
Fluoroscopic images will be taken in the anteroposterior plane, number of vertebral levels the injectate has spread out will be recorded.
0 minutes
The level of contrast spread in the anteroposterior plane
Fluoroscopic images will be taken in the anteroposterior plane, number of vertebral levels the injectate has spread out will be recorded.
30 minutes
Secondary Outcomes (6)
Contrast spread to paravertebral space
0 minutes
Contrast spread to paravertebral space
30 minutes
Contrast spread to epidural area
0 minutes
Contrast spread to epidural area
30 minutes
Pinprick test
0 minutes
- +1 more secondary outcomes
Study Arms (1)
patient
erector spinae plane block applied patients
Interventions
Patients will be placed in prone position. Mild sedation will be achieved by using 1-2 mg of midazolam and 50-75 µg of fentanyl iv. The application area will be visualized with General Electrics (GE) Logiq e Ultrasound device using 10-12 MHz linear probe or convex probe. Transverse process and erector spinae muscles will be visualised at the target vertebral level. Following local anesthesia (1-2 cc 2% lidocaine) application to the insertion site, a 20 gauge spinal needle will be inserted using the "in-plane" technique. The needle will be advanced up to the transverse process under ultrasound guidance. After confirming needle position with hydrodissection, 40 mg triamcinolone, 10 cc 0,5% bupivacaine, 10 cc radiopaque contrast agent solution will be injected. Imaging will performed in AP and lateral positions with fluoroscopy immediately and 30 minutes after the injection to evaluate intectate spread.
Eligibility Criteria
Patients who underwent erector spinae plane block for any reasons
You may qualify if:
- Age over 18 years old
- Patients who underwent erector spinae plane block for any reasons
You may not qualify if:
- Age under the age of 18
- Patients without a clear contrast spread under fluoroscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Halil Cetingok
Istanbul, Fatih, 34093, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Halil Cetingok, Ass. Prof.
Istanbul University Istanbul faculty of medicine department of pain medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 28, 2021
First Posted
November 9, 2021
Study Start
April 1, 2021
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
November 9, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share