PERIPHERAL NERVE BLOCKS WITH LOW DOSE LIGNOCAINE FOR THE TREATMENT OF ACUTE LUMBOSACRAL RADICULOPATHY
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- ≥50% or ≥4 point reduction in an 10-point numeric scale (NRS) at, 1 month, 2 months and 3 months.
研究概览
简要总结
Low back pain is one of the most common ailments that plagues patients, with nearly 80% of the population developing some form of back pain in their lifetime. Up regulated sodium channels in the nerve root or dorsal root ganglion are the basic cause for the mechano-sensitization and injecting the drug in the peripheral end of the nerve will block these sodium channels, since functionally both ends of the pseudo unipolar neuron are the same.
详细描述
Low back pain is one of the most common ailments that plague patients, with nearly 80% of the population developing some form of back pain in their lifetime. Of all the causes of low back pain, the most common is lumbar radicular pain which may result from irritation of the nerve fibers or dorsal root ganglia due to intervertebral disc prolapse, degenerative spondylolisthesis or spinal canal stenosis. [1] Up regulated sodium channels in the nerve root or dorsal root ganglion are the basic cause for the mechano-sensitization and injecting the drug in the peripheral end of the nerve will block these sodium channels, since functionally both ends of the pseudo unipolar neuron are the same. [2]There have yet been no studies done to prove the efficacy of peripheral nerve block as an alternative to lumbar epidurals. We would like to share our experience of peripheral nerve blocks with low dose local Anaesthetics as the treatment of acute lumbosacral radiculopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years to 60 years
- •Pain involving up to two segmental levels (L4, L5 and S1).
- •Average pain score of ≥5 on an 11-point NRS.
- •Tenderness over the concordant peripheral nerves (Gore sign +)
- •Computed tomography/Magnetic resonance imaging evidence of nerve root pain concordant with the side and level of clinical features.
排除标准
- •Coagulopathy and/or patients on anticoagulants.
- •Infection at the site of injection.
- •Hypersensitivity to a local anaesthetic agent.
- •Evidence of significant sensory or progressive motor deficit.
- •Presence of cancer as a cause of back pain.
- •History of previous backs surgery/epidural steroid injection.
结局指标
主要结局
≥50% or ≥4 point reduction in an 10-point numeric scale (NRS) at, 1 month, 2 months and 3 months.
时间窗: 3 months
change in pain intensity measured with numeric scale.Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an ten-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
次要结局
未报告次要终点
研究者
ADABALA VIJAY BABU
Principal Investigator
All India Institute of Medical Sciences, Rishikesh