Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- The volume and dose of local anesthetic injected epidurally, in combination with the steroid, will be measured against the duration and degree of pain relief.
研究概览
简要总结
The purpose of this study is to examine 4 different epidural dosing regimes of local anaesthetic solution in a series of 3 epidural injections over a period of 12 months to determine the optimum dose of anaesthetic solution for pain relief and to determine the nature of any adverse events by measuring anxiety and depression, functionality and any side effects of the medication.
详细描述
To determine the optimum dose of local anesthetic and the optimum volume of injected solution when used in an epidural steroid injection being given for pain relief to patients with chronic lower back pain, using pain scores as an assessment tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •lower back pains > 6 months
- •no lumbar epidural in past 6 months
- •no previous back surgery
- •written informed consent to participate in study
排除标准
- •acute lower back pain
- •pregnancy
- •significant psychiatric disease
- •local or systemic infection
- •coagulopathy/anticoagulant therapy
- •bleeding diathesis
- •presently enrolled in another study
研究组 & 干预措施
LV/LD 1
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
干预措施: Bupivacaine (Drug)
LV/LD 1
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
干预措施: Depo-Medrol (Drug)
LV/HD 2
Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
干预措施: Bupivacaine (Drug)
LV/HD 2
Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
干预措施: Depo-Medrol (Drug)
HV/LD 3
High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
干预措施: Bupivacaine (Drug)
HV/LD 3
High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
干预措施: Depo-Medrol (Drug)
HV/HD 4
High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
干预措施: Bupivacaine (Drug)
HV/HD 4
High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
干预措施: Depo-Medrol (Drug)
结局指标
主要结局
The volume and dose of local anesthetic injected epidurally, in combination with the steroid, will be measured against the duration and degree of pain relief.
时间窗: Pain scores will be measured at 6 time intervals throughout the study period, prior to 1st injection, 30 minutes post 1st injection, prior to 2nd injection and 3rd injections and at 3 and 6 month post the three month injection.
次要结局
- Secondary outcomes will be scores on the Oswestry low back pain disability scale and the Hospital anxiety and depression scale correlated with treatment outcomes and adverse events.(Oswestry scores and HADS scores will be calculated at 5 time periods throughout the study period, prior to 1st, 2nd, and 3rd injections and at 3 and 6 month post the three month injection.)