Halil Cetingok
Istanbul, Fatih, 34093, Turkey (Türkiye)
NCT Number: NCT05114200
The purpose of this study is to evaluate the injectate spread in erector spinae plane blocks under fluoroscopy.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Istanbul, Fatih, 34093, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
Time frame: 0 minutes
Pinprick test will be performed to determine hypoalgesia and/or analgesia in relevant dermatomes
Time frame: 30 minutes
Pinprick test will be performed to determine hypoalgesia and/or analgesia in relevant dermatomes
Istanbul University
Other
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.
NCT06679400
Facial Pain, Neurologic Manifestations
Ann Arbor, Michigan, United States
View Trial DetailsNCT04914637
Bone Diseases, Chronic Pain
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07292350
Back Pain, Neck Pain
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT01293019
Back Pain, Chest Pain
Paris, France
View Trial Details