Epidural Injection of Corticosteroids Under USG (EICUS) (EICUS)
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|ClinicalTrials.gov Identifier: NCT02860078|
Recruitment Status : Suspended (Not started)
First Posted : August 9, 2016
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain Management||Device: Ultrasound Device: Radioscopy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparative Study of the Use of Ultrasonography (USG) or Isolated Use of Fluoroscopy for Sacral Epidural Puncture Corticosteroid Infiltration in Patients With Low Back Pain by Canal Stenosis Lumbar|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Active Comparator: Ultrasound
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.
Location and function of sacral epidural space with ultrasound
Active Comparator: Radioscopy
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.
Location and puncture of the sacral epidural space only with fluoroscopy
- Pain management [ Time Frame: 1 year ]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.
- Satisfaction with treatment [ Time Frame: during the procedure ]Satisfaction with the treatment of pain is assessed using a numerical scale from 0 to 10, 0 being unsatisfied and 10 being complete satisfaction.
- Medications [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860078
|Shirley Andrade Santos|
|São Paulo, Brazil, 05408000|