Optimal-dose of Dexmedetomidine as Adjuvant to Epidural Local Anesthetic/Steroid Injectate to Improve Pain and Quality of Waking in Patients With Chronic Low Back Pain: A Randomized Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Spine Surgery.
研究概览
简要总结
Chronic low back pain (CLBP) is a prevalent condition causing significant pain, disability, and reduced quality of life. While various treatments like exercise, NSAIDs, and spinal manipulation are recommended, their effectiveness is limited. Epidural steroid injections can provide short-term relief but may not be cost-effective and have associated risks.
Dexmedetomidine (DXM) is a selective α2-adrenergic agonist with analgesic properties. It has been used as an adjuvant to anesthetics and analgesics to enhance pain relief and reduce opioid consumption. Using DXM in conjunction with local anesthetics for regional blocks has shown promising results in improving analgesia and functional outcomes.
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, Care Provider)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of daily activities;
- •Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of quality of walking and life;
- •Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks maintained on systemic analgesics;
- •Patients who were free of exclusion criteria were enrolled in the study.
排除标准
- •The presence of osteolytic vertebral lesions;
- •The Presence of previous surgical intervention;
- •The presence of allergy to the studied drugs;
- •Patients of ASA grade >II.
研究组 & 干预措施
Group I
干预措施: lidocaine and triamcinolone (Drug)
Group II
干预措施: Dexmedetomidine (Drug)
Group II
干预措施: lidocaine and triamcinolone (Drug)
Group III
干预措施: Dexmedetomidine (Drug)
Group III
干预措施: lidocaine and triamcinolone (Drug)
Group IV
干预措施: Dexmedetomidine (Drug)
Group IV
干预措施: lidocaine and triamcinolone (Drug)
Group V
干预措施: Dexmedetomidine (Drug)
Group V
干预措施: lidocaine and triamcinolone (Drug)
结局指标
主要结局
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Spine Surgery.
时间窗: 3 months
Value of Dexmedetomidine injection in Pain Reduction post operatively manifested by recurrence of pain.
次要结局
未报告次要终点
研究者
Ahmed M Helwa
Lecturer of Anesthesia, Pain & ICU
Menoufia University