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

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114200
• Other study ID #: 2021/467
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2021
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Facial Pain

Intervention

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.

Locations

Country	Name	City	State
Turkey	Halil Cetingok	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pinprick test	Pinprick test will be performed to determine hypoalgesia and/or analgesia in relevant dermatomes	0 minutes
Secondary	Pinprick test	Pinprick test will be performed to determine hypoalgesia and/or analgesia in relevant dermatomes	30 minutes