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

Completed

• Conditions: Pain, Myofacial; Back Pain
• Interventions: Procedure: Erector spinae plane block

• Registration Number: NCT05114200
• Lead Sponsor: Istanbul University

Brief Summary

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

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 Timeline

• Study Start: 2021-04-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Study First Submitted: 2021-09-28
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-06
• Last Update Submitted: 2021-11-06
• Study First Posted: 2021-11-09
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient	Erector spinae plane block	erector spinae plane block applied patients

Primary Outcome Measures

Name	Time	Method
The level of contrast spread in the anteroposterior plane	30 minutes	Fluoroscopic images will be taken in the anteroposterior plane, number of vertebral levels the injectate has spread out will be recorded.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Halil Cetingok; 🇹🇷 Istanbul, Fatih, Turkey