Epidural Injection of Corticosteroids Under USG (EICUS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pain Management

Intervention / Treatment
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* Device: Ultrasound
* Device: Radioscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years old; Patients who have low back and/or lower extremities due to lumbar spinal stenosis pain outpatients, with regular follow-up refractory to conservative medical treatment (Verbal Scale of Pain > 3, more three months duration, with no improvement with clinical treatment). Exclusion Criteria: Symptoms that characterize a surgical emergency; The presence of sensory or motor deficit (chronic mild motor impairment or mild paresthesia will not be deleted), injury to peripheral nerves, trauma history or recent fracture; Serious medical conditions or decompensated; Infection at the puncture site; Coagulopathy; Contrast allergy history or the medications used in the technique; Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound<br>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. | Device: Ultrasound<br>* Location and function of sacral epidural space with ultrasound<br>|
| Active Comparator: Radioscopy<br>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. | Device: Radioscopy<br>* Location and puncture of the sacral epidural space only with fluoroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, epidural, ultrasound