Skip to main content
OpenTrials
Completed

NCT Number: NCT05114200

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Halil Cetingok

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years old
  • Patients who underwent erector spinae plane block for any reasons

Exclusion criteria

  • Age under the age of 18
  • Patients without a clear contrast spread under fluoroscopy

Treatment and study plan

Erector Spinae Plane Block

Procedure

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.

Primary outcomes

  1. The level of contrast spread in the anteroposterior plane

    Time frame: 0 minutes

    Fluoroscopic images will be taken in the anteroposterior plane, number of vertebral levels the injectate has spread out will be recorded.

  2. The level of contrast spread in the anteroposterior plane

    Time frame: 30 minutes

    Fluoroscopic images will be taken in the anteroposterior plane, number of vertebral levels the injectate has spread out will be recorded.

Secondary outcomes

  1. Contrast spread to paravertebral space

    Time frame: 0 minutes

    Fluoroscopic images will be taken in the anteroposterior and lateral plane, and contrast spread to the paravertebral space will be recorded.

  2. Contrast spread to paravertebral space

    Time frame: 30 minutes

    Fluoroscopic images will be taken in the anteroposterior and lateral plane, and contrast spread to the paravertebral space will be recorded.

  3. Contrast spread to epidural area

    Time frame: 0 minutes

    Fluoroscopic images will be taken in the anteroposterior and lateral planes, and contrast spread to the epidural area will be recorded.

  4. Contrast spread to epidural area

    Time frame: 30 minutes

    Fluoroscopic images will be taken in the anteroposterior and lateral planes, and contrast spread to the epidural area will be recorded.

  5. Pinprick test

    Time frame: 0 minutes

    Pinprick test will be performed to determine hypoalgesia and/or analgesia in relevant dermatomes

  6. Pinprick test

    Time frame: 30 minutes

    Pinprick test will be performed to determine hypoalgesia and/or analgesia in relevant dermatomes

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2021
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.