跳至主要内容
临床试验/CTRI/2025/03/081699
CTRI/2025/03/081699尚未招募2 期

To study the effectiveness of lumbar epidural dexamethasone with bupivacaine versus triamcinolone with bupivacaine in patients with prolapsed intervertebral disc

Dr Abhimanyu Dehal1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To systematically evaluate and compare the therapeutic effectiveness of lumbar epidural route injections containing dexamethasone versus triamcinolone in managing pain and enhancing functional outcomes in patients diagnosed with prolapsed intervertebral disc.

研究概览

简要总结

A prolapsed intervertebral disc in the spine is a condition during which a nucleus pulposus is displaced from intervertebral space. It is a common cause of back pain.

Several nonsurgical medical treatments have been proposed for lumbosacral radicular pain, from lifestyle changes, exercise and physical therapy to analgesic local/oral drugs and epidural steroid injections (ESIs).

An ESI is a common and minimally invasive procedure, performed to successfully treat lumbosacral radicular pain, which has also proved its effectiveness in the treatment of acute back pain and leg symptoms. The injections are used to deliver steroids, and sometimes local anaesthetics, to the epidural space, directly to the site that causes the pain using a caudal, interlaminar route. The preparation of steroids used in the epidural space can be divided into 2 groups particulate such as methylprednisolone, betamethasone, and triamcinolone; and non- particulate like dexamethasone phosphate. Corticosteroids decrease inflammation through inhibition of prostaglandins in the arachidonic acid cascade, which may improve microcirculation through decreasing capillary permeability, nerve root oedema, and ischemia.Steroids also directly inhibit the excitation of pain-generating c-fibre neurons.Various steroid preparations are utilized for Epidural Steroid Injections (ESIs), including dexamethasone, triamcinolone, betamethasone, and methylprednisolone along with local anesthetics. The Aim of our study is to systematically evaluate and compare the therapeutic effectiveness of lumbar epidural injections containing dexamethasone versus triamcinolone in managing pain and enhancing functional outcomes in patients diagnosed with prolapsed intervertebral disc, contributing valuable insights to optimize treatment approaches for this common spinal condition.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Individuals aged 18-70 years 2.Failed conservative treatment of PIVD for over 6 weeks
  • Chronic lumbar radiculopathy
  • Radiographic imaging (such as CT-scan or MRI) indicating the presence of either a herniated disc causing irritation or compression of a nerve root.

排除标准

  • Contraindications to the procedure itself, including active, local, or systemic infection, unstable medical conditions, coagulopathy, or the use of anti-thrombotic or anti-platelet medication, excluding aspirin, and allergy to contrast medium or injected medication.
  • Presence of cauda equina syndrome.
  • Back and lower extremity pain attributed to tumour origin, infections, or inflammatory pathologies of back.
  • Pregnancy or nursing.

结局指标

主要结局

To systematically evaluate and compare the therapeutic effectiveness of lumbar epidural route injections containing dexamethasone versus triamcinolone in managing pain and enhancing functional outcomes in patients diagnosed with prolapsed intervertebral disc.

时间窗: results will enable us to assess and contrast the proportion of patients experiencing over 50% pain relief at designated follow-up time points of 1 hour, 24 hours, 15 days, 1 month and 3 month utilizing the VAS (Visual Analog Scale) Score.

次要结局

  • Compare particulate steroids versus non particulate steroid for pain relief, and duration of Pain Relief.(Successful treatment outcome will be considered in patients with 50% reduction in VAS score from baseline after 3 months.)

研究者

发起方
Dr Abhimanyu Dehal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Abhimanyu Dehal

Department of Anaesthesiology MMCH Solan

研究点 (1)

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