Evaluation of Drug Spread in Ultrasound-Guided Erector Spina Plane Block With Fluoroscopy

The purpose of this study is to evaluate the injectate spread in erector spinae plane blocks under fluoroscopy.

Study Overview

• Status: Completed
• Conditions: Back Pain; Pain, Myofacial
• Intervention / Treatment: Procedure: Erector spinae plane block

Detailed Description

The study will be carried out between March 2021 and June 2021 in Istanbul University Istanbul Medical Faculty Pain Medicine Clinic. Patients who undergone erector spinae plane block for any indication over the age of 18 will be included in the study.

All procedures will be performed in the operating room under standard monitorization (ECG, pulse oximetry, non-invasive blood pressure) and all patients will be in the prone position. The application area will be sterilized with povidone-iodine solution. Mild sedation will be achieved by using 1-2 mg of midazolam and 50-75 µg of fentanyl iv. The target area will be visualized by General Electrics (GE) Logiq e Ultrasound device using a 10-12 MHz linear probe or 1-4 MHz curvilinear probe. Transverse processes and erector spina muscles will be visualised at the target vertebral level. After local anesthesia (1-2 cc 2% lidocaine), a 20 gauge spinal needle will be inserted using the "in-plane technique". The needle will be advanced to the transverse process, after it's position is confirmed with hydrodissection, a solution of 40 mg triamcinolone, 10 ml 0,5% bupivacaine, 10 ml radiopaque contrast agent will be injected. Contrast spread will be evaluated with the fluoroscopy in the anterior-posterior and lateral positions immediately and 30 minutes after the procedure. The level of contrast radiating in the AP plane and passing through the paravertebral space and the epidural distance in the lateral plane will be noted. In addition, sensory examination with a pin prick test will be performed to determine the presence of dermatomal hypoalgesia and/or analgesia.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Halil Çetingök

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent erector spinae plane block for any reasons

Description

Inclusion Criteria:

1. Age over 18 years old
2. Patients who underwent erector spinae plane block for any reasons

Exclusion Criteria:

1. Age under the age of 18
2. Patients without a clear contrast spread under fluoroscopy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patient; erector spinae plane block applied patients

Procedure: Erector spinae plane block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast spread to paravertebral space	Fluoroscopic images will be taken in the anteroposterior and lateral plane, and contrast spread to the paravertebral space will be recorded.	0 minutes
Contrast spread to paravertebral space	Fluoroscopic images will be taken in the anteroposterior and lateral plane, and contrast spread to the paravertebral space will be recorded.	30 minutes
Contrast spread to epidural area	Fluoroscopic images will be taken in the anteroposterior and lateral planes, and contrast spread to the epidural area will be recorded.	0 minutes
Contrast spread to epidural area	Fluoroscopic images will be taken in the anteroposterior and lateral planes, and contrast spread to the epidural area will be recorded.	30 minutes
Pinprick test	Pinprick test will be performed to determine hypoalgesia and/or analgesia in relevant dermatomes	0 minutes
Pinprick test	Pinprick test will be performed to determine hypoalgesia and/or analgesia in relevant dermatomes	30 minutes

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Halil Cetingok, Ass. Prof., Istanbul University Istanbul faculty of medicine department of pain medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: November 6, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 6, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Erector spinae plane block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Facial Pain
• Other Study ID Numbers: 2021/467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No