Epidural Injection of Corticosteroids Under USG (EICUS)

NCT02860078 | Withdrawn DMC

• 1 other identifier: 56795916.8.0000.0068
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management

Keywords

pain; epidural; ultrasound

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Device: Ultrasound

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.

Device: Radioscopy

Interventions

Ultrasound DEVICE

Location and function of sacral epidural space with ultrasound

Ultrasound

Radioscopy DEVICE

Location and puncture of the sacral epidural space only with fluoroscopy

Radioscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Shirley Andrade Santos

São Paulo, 05408000, Brazil

Location

Related Publications (6)

• 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.

  PMID: 15220789 BACKGROUND

• 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.

  PMID: 9322469 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.

  PMID: 9840855 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.

  PMID: 27008296 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.

  PMID: 22828681 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.

  PMID: 20869897 RESULT

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: August 9, 2016
• Study Start: January 17, 2021
• Primary Completion: January 17, 2021
• Study Completion: January 17, 2021
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)