Ambulatory Infusion of Lidocaine and Ketamine for Management of Chronic Pain: An Observational Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 主要终点
- Pain Unpleasantness Score
研究概览
简要总结
Chronic pain is defined as 'an unpleasant sensory and emotional experience associated with actual or potential tissues damage, or described in terms of such damage". It is estimated that 1 in 5 Canadians experience chronic pain "Chronic pain is associated with the worst quality of life compared with other chronic diseases such as chronic lung or heart disease". Many of these problems are confined to a specific anatomic structure, and can be diagnosed and treated by injections, physical therapy, surgery, etc. Nonetheless, other individuals experience a more generalized pain. This condition has also resulted I depressed mood, bad relations with other people, sleep disturbances and poor quality of life.
The condition is very difficult to manage, and multiple methods have been recommended. Therapeutic intravenous infusion may be considered as one of these methods. Patients come for infusions of non-opioid medications under medical supervision and in a scheduled fashion. Two most commonly used mediation are lidocaine and ketamine.
Even though it is common to use multiple medications with complementary mechanisms of action to treat pain a combined lidocaine-ketamine infusion has never been studied Therefore, the purpose of this research study is to determine whether mixture of two medications (ketamine and lidocaine) infused intravenously 1 time per month for 6 months results in reduction of pain unpleasantness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90
- •Pain duration: > 3 months
- •Multifocal and/or non-dermatomal neuropathic pain per Pain Diagram
- •Failed medical management with at least 2 neuromodulation agents (e.g., gabapentinoids, antidepressants)
- •Neuropathic component (>15 points on S-LANSS)
排除标准
- •Non-English speakers
- •Refusal to sign informed consent
- •Body weight > 100 kg
- •Allergies to ketamine and/or lidocaine
- •Known contraindications to ketamine use which include poorly controlled systemic illnesses: arterial hypertension, hyperthyroidism, ischemic heart disease, heart failure, psychiatric comorbidity (e.g., history of psychosis, schizophrenia, dissociative state).
- •Known contraindication to lidocaine use which include current symptomatic or clinically significant brady- or tachyarrhythmia, systolic blood pressure <90 or >180 mmHg.
- •Scheduled interventions targeting neuropathic pain: epidural injections, peripheral nerve blocks, Bier block, radiofrequency of dorsal root ganglia and peripheral nerves, additional lidocaine or ketamine infusions
- •Newly added analgesic or neuromodulating medications, or recently performed interventions including lidocaine infusions (in the previous 3 months), or previous lidocaine/ketamine infusion in the previous 360 days. -Acute intoxication or active illegal substance abuse (excluding marijuana)
研究组 & 干预措施
Lidocaine-Ketamine Infusion
Lidocaine-Ketamine Infusions 1 time per month for 6 months. Pretreatment with Midazolam 1-3 mg IV Push or Subcutaneously and Clonidine 0.1 mg PO prior to infusion.
干预措施: Lidocaine (Drug)
Lidocaine-Ketamine Infusion
Lidocaine-Ketamine Infusions 1 time per month for 6 months. Pretreatment with Midazolam 1-3 mg IV Push or Subcutaneously and Clonidine 0.1 mg PO prior to infusion.
干预措施: Ketamine (Drug)
结局指标
主要结局
Pain Unpleasantness Score
时间窗: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Relative change on "Pain Unpleasantness Score". Moderate clinically important improvement is considered as 30% reduction.
次要结局
- Neuropathic Pain(Baseline, 1, 2, 3, 4, 5, 6 and 12 Months)
- Functional Status(Baseline, 1, 2, 3, 4, 5, 6 and 12 Months)
- Emotional Status(Baseline, 1, 2, 3, 4, 5, 6 and 12 Months)
- Health Care Utilization(Baseline, 1, 2, 3, 4, 5, 6 and 12 Months)
- Medication Use(Baseline, 1, 2, 3, 4, 5, 6 and 12 Months)
- Cognitive Status(Baseline, 1, 2, 3, 4, 5, 6 and 12 Months)
- Pain Interference(Baseline, 1, 2, 3, 4, 5, 6 and 12 Months)
- Quality of Life(Baseline, 1, 2, 3, 4, 5, 6 and 12 Months)
研究者
Michael Gofeld
Anesthesiologist
Hamilton Health Sciences Corporation