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Epidural Injection of Corticosteroids Under USG (EICUS) (EICUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860078
Recruitment Status : Suspended (Not started)
First Posted : August 9, 2016
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
SHIRLEY ANDRADE SANTOS, University of Sao Paulo General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Management Device: Ultrasound Device: Radioscopy Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: Ultrasound
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.
Device: Radioscopy
Location and puncture of the sacral epidural space only with fluoroscopy




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Brazil
Shirley Andrade Santos
São Paulo, Brazil, 05408000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Publications of Results:
Other Publications:
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Responsible Party: SHIRLEY ANDRADE SANTOS, M.D., University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02860078    
Other Study ID Numbers: 56795916.8.0000.0068
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SHIRLEY ANDRADE SANTOS, University of Sao Paulo General Hospital:
pain
epidural
ultrasound