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Qualitative and quantitatively evaluate the pain control and incidence of adverse effects in patients undergoing corticosteroid infiltration and local anesthetic through sacral epidural puncture with ultrasound assistance or isolated use of fluoroscopy to aid puncture and location of the sacral epidural space. A group will be submitted to epidural corticosteroid infiltration associated with local anesthetic with the use of fluoroscopy for locating the sacral epidural space, which is currently the gold standard for this technique, while in another location group will be held with the use of ultrasound.
Introduction: Procedures guided by ultrasound (USG) have advantages over traditional techniques (fluoroscopy) with respect to regional anesthesia. Some studies have shown its usefulness as a quick, safe and simple tool for the location of the sacral hiatus and to guide the puncture of the sacral epidural space in patients with chronic low back pain, despite the lack of data with respect to clinical outcomes.
OBJECTIVES: Evaluate qualitatively and quantitatively the pain control and incidence of adverse effects in patients undergoing corticosteroid infiltration and local anesthetic through sacral epidural puncture with ultrasound assistance or isolated use of fluoroscopy to aid puncture and location of the sacral epidural space. It will also be evaluated success rate in the first puncture, and the time duration of the procedure in groups.
METHODS: It is clinical, analytical, prospective trial, randomized, covered for evaluators. It will include 30 patients with chronic low back pain or pain in the lower limbs resulting in lumbar canal stenosis, refractory to medical treatment. A group will be submitted to epidural corticosteroid infiltration associated with local anesthetic with the use of fluoroscopy for locating the sacral epidural space, which is currently the gold standard for this technique, while in another location group will be held with the use of ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound | Active Comparator | The group I will be subjected to epidural infiltration using methylprednisolone acetate diluted in ropivacaine 0.1%. Initially the sacral hiatus is identified by palpation. After, the ultrasound device is used (USG) for the puncture, with a linear transducer of high frequency. At the end of corticosteroid administration, the placement of the needle tip will be checked with fluoroscopy and noted. |
|
| Radioscopy | Active Comparator | The group II will be subjected to infiltration using methylprednisolone acetate diluted in ropivacaine 0.1% . However, only radioscopy be used to guide the puncture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | Location and function of sacral epidural space with ultrasound |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain management | After infiltration, the patient will be reassessed as to pain control in 15 days, 3, 6 and 12 months. Pain is assessed using a verbal analog scale (VAS) from 0 to 10, with 0 being no pain and 10 being the worst possible pain. Patients will quantify the pain at rest, improvement factors and worse, smaller and higher scores during the day, and average daily pain. | 1 year |
| Satisfaction with treatment | Satisfaction with the treatment of pain is assessed using a numerical scale from 0 to 10, 0 being unsatisfied and 10 being complete satisfaction. | during the procedure |
| Medications | It will be noted and all medications used by the patient before the procedure, and their doses, repeating the notes after 3 months of follow-up after the block. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Andrade Santos | São Paulo | 05408000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15220789 | Background | Chen CP, Tang SF, Hsu TC, Tsai WC, Liu HP, Chen MJ, Date E, Lew HL. Ultrasound guidance in caudal epidural needle placement. Anesthesiology. 2004 Jul;101(1):181-4. doi: 10.1097/00000542-200407000-00028. | |
| 9322469 | Result | Marhofer P, Schrogendorfer K, Koinig H, Kapral S, Weinstabl C, Mayer N. Ultrasonographic guidance improves sensory block and onset time of three-in-one blocks. Anesth Analg. 1997 Oct;85(4):854-7. doi: 10.1097/00000539-199710000-00026. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Radioscopy |
| Device |
Location and puncture of the sacral epidural space only with fluoroscopy |
|
| 9840855 | Result | Marhofer P, Schrogendorfer K, Wallner T, Koinig H, Mayer N, Kapral S. Ultrasonographic guidance reduces the amount of local anesthetic for 3-in-1 blocks. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):584-8. doi: 10.1016/s1098-7339(98)90086-4. |
| 27008296 | Result | Manchikanti L, Knezevic NN, Boswell MV, Kaye AD, Hirsch JA. Epidural Injections for Lumbar Radiculopathy and Spinal Stenosis: A Comparative Systematic Review and Meta-Analysis. Pain Physician. 2016 Mar;19(3):E365-410. |
| 22828681 | Result | Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: a randomized, controlled, double blind trial with a two-year follow-up. Pain Physician. 2012 Jul-Aug;15(4):273-86. |
| 20869897 | Result | Blanchais A, Le Goff B, Guillot P, Berthelot JM, Glemarec J, Maugars Y. Feasibility and safety of ultrasound-guided caudal epidural glucocorticoid injections. Joint Bone Spine. 2010 Oct;77(5):440-4. doi: 10.1016/j.jbspin.2010.04.016. Epub 2010 Sep 24. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |