The Effect of Ultrasound Guidance on Radiation Dose and Procedure Time in Lumbar Transforaminal Epidural Injection
NCT05793528 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50
Last updated 2023-03-31
Summary
Low back pain is one of the leading causes of disability, and its social burden and economic cost are quite high. Although there are many causes that can lead to low back pain, radicular pain, which develops mostly secondary to lumbar disc hernias, is one of the most common pathologies. Epidural corticosteroid and local anesthetic injections are an important treatment option in the treatment of lumbar radicular pain that does not respond to conservative methods.
For fluoroscopy-guided epidural injections; transforaminal, interlaminar and caudal approaches may be preferred. It is accepted as the superiority of the transforaminal approach that it allows access to the area of pathology, thus to the anterior epidural area where inflammatory mediators are more concentrated, and that it can spread to the target specifically around the inflamed nerve roots.
In transforaminal epidural injections, the use of ultrasound as the sole imaging tool throughout the entire procedure is still not appropriate, as subbony structures cannot be visualized. However, ultrasound can be integrated at any stage of the process. Thus, the relatively inexpensive cost, portability, and ability to show non-osseous tissues of ultrasonography are utilized, particularly in terms of reducing radiation exposure.
Gofeld et al. claimed that ultrasound-guided transforaminal epidural injection could be performed by targeting the posterior part of the vertebral body. However, in cases where the lamina is wide and covers the posterior of the vertebral body, it may not be possible to sonographically view the vertebral body. In addition, although the intervertebral disc is differentiated from the corpus, loss of fluid content in the elderly can cause acoustic shadowing in the disc. This may result in accidental intra-disc injections. Finally, even if the target point is reached, it is not possible to show intravascular spread at this level ultrasonographically. Therefore, in our opinion, this method is unreliable for transforaminal epidural injections. Another study used ultrasound and fluoroscopy together for transforaminal epidural injections. After imaging the lamina of the relevant vertebral level sonographically, the needle is directed to the lateral edge of the lamina, then fluoroscopic imaging is performed after it passes under the lamina with the loss of resistance technique. However, it should be known that the loss of resistance technique is not a suitable and reliable method in transforaminal injections. In addition, since it is not known how far the lamina has progressed after it has passed under the bone, in other words, imaging guidance is disabled in this part of the process.
In our clinic, we use ultrasonography and fluoroscopy methods in an integrated way (hybrid method) for transforaminal epidural injections. For this purpose, we proceed to fluoroscopic imaging immediately after the spinal needle is advanced to the lateral edge of the lamina at the vertebral level where there is pathology with ultrasound. We think that with this method, we continue to stay in the safe window and reduce the radiation dose and procedure time. Based on this, we determined the aim of this study as the effect of including ultrasonography guidance in transforaminal epidural injections on radiation dose and procedure time.
Conditions
- Lumbar Disc Herniation
- Radiculopathy Lumbar
Interventions
- PROCEDURE
-
Fluoroscopy Guided Transforaminal Epidural Steroid Injection
The patients are positioned prone. The injection site is cleaned with povidone-iodine 3 times and a sterile drape was applied. Short-acting local anesthesia (3 mL of 2% prilocaine) is applied to the skin and subcutaneous tissue. A 3.5-inch, 22-gauge spinal needle is inserted just below the pedicle. It is advanced into the subpedicular space using the coaxial technique under the intermittent guidance of fluoroscopy. The needle position is confirmed through a lateral view. Using lateral views, the needle is placed at the posterior one-third of the foramen. Using the anteroposterior view, one to 2 mL of the contrast agent (300 mg/50 mL iohexol) is given and the distribution pattern is visualized. Once the epidural distribution of the contrast agent is confirmed without vascular flow, a mixture of 8 mg (two mL) of dexamethasone, 1 mL of physiological saline, and 1 mL (0.5%) of bupivacaine hydrochloride is injected.
- PROCEDURE
-
Ultrasound Guided Transforaminal Epidural Steroid Injection
The patients are positioned prone placed. Following the provision of aseptic conditions, the spinous process of the vertebral midline is visualized using a low-frequency convex ultrasound probe. The lateral edge of the relevant vertebral lamina is visualized by sonographic scanning in the horizontal plane. Local anesthesia is applied to the skin and subcutaneous tissue. A 3.5-inch, 22-gauge spinal needle is advanced to the lateral edge of the relevant vertebral lamina under ultrasound image guidance. Then, anteroposterior imaging is performed with fluoroscopy to confirm needle localization when the lamina margin is reached, and the needle is guided into the foramen under the guidance of fluoroscopy. The contrast agent is given and the distribution pattern is visualized. Once the epidural distribution of the contrast agent is confirmed without vascular flow, a mixture of 2 mL of dexamethasone, 1 mL of physiological saline, and 1 mL (0.5%) of bupivacaine hydrochloride is injected.
Sponsors & Collaborators
-
Marmara University
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-05-01
- Primary Completion
- 2023-09-01
- Completion
- 2023-11-01
Countries
- Turkey (Türkiye)
Study Locations
More Related Trials
-
Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections
NCT05729022 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Erector Spinae Plane Block vs Transforaminal Epidural Injection
NCT04212845 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification
NCT06275529 ·Status: COMPLETED ·Phase: NA
-
Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain
NCT04930211 ·Status: UNKNOWN ·Phase: NA
-
Relief of Lumbar Spinal Stenosis Symptoms
NCT06393959 ·Status: RECRUITING ·Phase: NA
-
Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy
NCT05711121 ·Status: UNKNOWN ·Phase: NA
-
Transforaminal and Parasagittal Approach in Lumbar Epidural Steroid Injection
NCT05551676 ·Status: UNKNOWN ·Phase: NA
-
Epidural Steroid Injections in Post-lumbar Surgery Syndrome After Single-level Discectomy
NCT05099796 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy
NCT02025283 ·Status: COMPLETED
-
Impact of Cervical Parameters to Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients With Cervical Disc Herniation
NCT05374850 ·Status: UNKNOWN
-
Effect of Pulsed Mode Radiofrequency as a Treatment of Lumbar Disc Related Radicular Pain on Tumor Necrotic Factor α Level
NCT05288920 ·Status: COMPLETED ·Phase: PHASE1
-
The Aim of Study is to Identify the Predictive Factors for the Success of Transforaminal Epidural Injection in Treatment of Patients with Lumbosacral Radiculopathy
NCT06795542 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
Radiation Exposure in Spine Intervention Under Angiography
NCT01751958 ·Status: COMPLETED ·Phase: PHASE3
-
Glucocorticoid Injection in Patients With Lumbar Radicular Pain
NCT05571046 ·Status: COMPLETED ·Phase: PHASE4
-
Artificial Intelligence (AI)-Based Prediction of Treatment Response in Sciatica Patients Receiving Transforaminal Epidural Steroid Injection
NCT07080307 ·Status: NOT_YET_RECRUITING
-
Statin and Epidural Steroid Injection
NCT02162940 ·Status: COMPLETED
-
Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy
NCT02358291 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis
NCT01052571 ·Status: COMPLETED ·Phase: NA
-
US-MR Image Fusion-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation
NCT03403244 ·Status: UNKNOWN ·Phase: NA
-
Lumbar Disc Hernia, Erector Spinae Plane Block, Ilesi
NCT07184554 ·Status: RECRUITING ·Phase: NA
-
Radiological Lumbar Spinal Stenosis Level and Patient Questionnaires
NCT07058350 ·Status: COMPLETED
-
Ultrasound-guided Caudal or Interlaminar Corticosteroid Epidural Injection for Sciatica
NCT02897336 ·Status: WITHDRAWN ·Phase: NA
-
Fluoroscopy Guided Lumbar Facet Joint Injection Versus Ultrasound Guided Injection in Patients With Low Back Pain Due to Facet Syndrome
NCT03770585 ·Status: COMPLETED ·Phase: NA
-
Ultrasound Localization in Thoracic Surgery - is Radiation Reduction Achievable?
NCT05968950 ·Status: UNKNOWN ·Phase: NA
-
Spine Ultrasound Image Study of Spondylolisthesis Patient
NCT04426916 ·Status: COMPLETED