NCT05370963已完成早期 1 期
Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial
Minia University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pain assesment
研究概览
简要总结
hyalase and dexmedtemodine are well known adjuvants given epidurally to alleviate chronic back pain. Use in failed back surgery is an up to date field to hasten analgesia and py off recurrence .
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, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group. 25-75ys old
- •Both sex.
- •persistent (at least 6 month) pain and or disability following laminectomy with or without sensory-motor neurological deficits or any form of urinary or bowel incontinence
- •Patients suffering from persistent (> 6 months) back pain following laminectomy for spinal canal stenosis and/or discectomy for herniated nucleus pulposus documented by magnetic resonance imaging (MRI) were included for screening and enrollment.
排除标准
- •Diabetic patients.
- •Refusal to participate
- •MRI with disc sequestration, concurrent sacro-ilitis, facet arthropathy .
- •Coagulopathic patients
- •Surgical induced discitis.
研究组 & 干预措施
hyalase group
Active Comparator
Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Hyaluronidase 1,500 IU reconstituted in 1 mL distilled water (HYL)
干预措施: Hylase versus dexmedtemodine (Drug)
dexmedtemodine group
Active Comparator
Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Dexmedetomidine 0.5 mic/kg
干预措施: Hylase versus dexmedtemodine (Drug)
结局指标
主要结局
pain assesment
时间窗: 6 months
Visual analogue scale... 0= no pain .... 10= worst pain
次要结局
- acute complications(6 hours)
- functional disability(6 months)
研究者
Mina Maher
Lecturer of anesthesia and ICU
Minia University
研究点 (1)
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