NCT05349448Unknown早期 1 期
Can Dexmedetomidine With Hyalase Augment Quality and Duration of Analgesia When Added to Lumbar Epidural Steroid in Failed Back Surgery. Randomized Double Blind Study
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3月28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
- 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
use of dexmedtemodine to augment analgesia in cases of failed back surgery
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 70 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
研究组 & 干预措施
solo 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 plus Triamcinolone plus sterile isotonic saline (Drug)
dex plus hyalase group
Active Comparator
Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Dexmedetomidine 0.5mic/kg + Hyaluronidase 1,500 IU reconstituted in 1 mL distilled water (HYL)+ Saline solution (2 mL)
干预措施: Hylase plus Dexmedetomidine plus Triamcinolone (Drug)
结局指标
主要结局
pain assesment
时间窗: 6 months
visual analogue scale
次要结局
- acute complications(6 hours after injection)
- functional diability(6 months)
研究者
Mina Maher
Lecturer of anesthesia and ICU
Minia University
研究点 (1)
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