A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection

Navamindradhiraj University

Status: Completed

Conditions: Lumbosacral Spondylosis; Radiculopathy; Spinal Stenosis

Treatments: Drug: Triamcinolone Acetonide and normal saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02939482

COA 74/2559

Details and patient eligibility

About

The purpose of this study is to determine the effects of different rates of Caudal Epidural Steroid Injection (CESI) on clinical outcomes of the patients.

Enrollment: 112 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• lumbosacral spinal stenosis with radiculopathy
• no improvement after conservative treatment for 6 weeks

Exclusion criteria

• previous CESI or spinal surgery
• skin infection at injection site
• uncontrolled diabetes mellitus
• abnormal coagulogram
• vertebral fracture
• previous history of allergy to steroid or anesthetic agent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 2 patient groups

Group 1: 40 ml/min

Active Comparator group

Description:

Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 0.5 min

Treatment:

Drug: Triamcinolone Acetonide and normal saline solution

Group 2: 20 ml/min

Experimental group

Description:

Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 1 min

Treatment:

Drug: Triamcinolone Acetonide and normal saline solution