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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05114200
Enrollment
50
Registered
2021-11-09
Start date
2021-04-01
Completion date
2021-06-30
Last updated
2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Pain, Myofacial

Keywords

Erector spinae plane block

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.

Interventions

PROCEDUREErector 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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The level of contrast spread in the anteroposterior plane0 minutesFluoroscopic images will be taken in the anteroposterior plane, number of vertebral levels the injectate has spread out will be recorded.

Secondary

MeasureTime frameDescription
Contrast spread to paravertebral space0 minutesFluoroscopic images will be taken in the anteroposterior and lateral plane, and contrast spread to the paravertebral space will be recorded.
Contrast spread to epidural area0 minutesFluoroscopic images will be taken in the anteroposterior and lateral planes, and contrast spread to the epidural area will be recorded.
Pinprick test0 minutesPinprick test will be performed to determine hypoalgesia and/or analgesia in relevant dermatomes

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026