Epidural Injection of Corticosteroids Under USG (EICUS)

University of Sao Paulo General Hospital

Status: Withdrawn

Conditions: Pain Management

Treatments: Device: Ultrasound; Device: Radioscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02860078

56795916.8.0000.0068

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

Ultrasound

Active Comparator group

Description:

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.

Treatment:

Device: Ultrasound

Radioscopy

Active Comparator group

Description:

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.

Treatment:

Device: Radioscopy