Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain: an Observational Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Evaluation of effectiveness of lidocaine-ketamine infusions: PQAS-R
研究概览
简要总结
As lidocaine and ketamine provide analgesia by acting on different molecular pathways, administering them together may produce synergistic effects, which can allow for using a lower dose of each medication and thereby reducing the corresponding side effects. To the investigator's knowledge, despite the common practice of multimodal analgesia, lidocaine-ketamine infusions have never been studied prospectively in an out of hospital setting to treat neuropathic pain. The aim of the present study is to evaluate the effectiveness of the current routine practice of lidocaine-ketamine infusions conducted at Allevio Pain Management Clinic, a large outpatient community based chronic pain management facility. Lidocaine-ketamine infusions are prescribed to patients that have pain that is considered to be neuropathic for which standard anti-neuropathic medications have been ineffective or poorly tolerated by patients. A prospective longitudinal study.
详细描述
Study objectives
- To evaluate effectiveness of lidocaine-ketamine infusions in reducing neuropathic pain, as assessed using the Revised Pain Quality Assessment Scale (PQAS-R) and Short Form Brief Pain Inventory (BPI-SF).
- To evaluate the effects of lidocaine-ketamine infusions on the measures of Global Improvement and Satisfaction Score, Pain Self-Efficacy Questionnaire (PSEQ), Pain Catastrophic Scale (PCS), Beck Depression Inventory (BDI), and Patient self-reported perceived duration of effect (PSPDE).
- To assess, analyze, and report adverse events
The study will be conducted per IMMPACT recommendations (17). Multi variable parameters will be captured: pain unpleasantness, physical function, emotional function, global improvement and satisfaction with treatment, adverse events and disposition. Additional instruments will be used in the triage process and follow-up (S-LANSS, PSEQ).
Number of subjects: all eligible consecutive patients accepted for lidocaine-ketamine infusions over period of 6 months.
Patients with multi focal and/or non-dermatomal pain with neuropathic component will be included.
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
- •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, cannabinoids);
- •Neuropathic component (12 or more points on S-LANSS);
排除标准
- •Non-English speakers;
- •Refusal to sign informed consent;
- •Allergy to ketamine and/or lidocaine;
- •Known relative contraindications to ketamine use which include poorly controlled systemic illnesses: hypertension, hyperthyroidism, ischemic heart disease, heart failure, psychiatric comorbidity (e.g., 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 within 30 days;
- •Recently performed neuromodulating interventions within 90 days;
- •Previous lidocaine-ketamine, lidocaine or ketamine infusion within 6 months;
- •Acute intoxication or active illegal substance abuse;
研究组 & 干预措施
Lidocaine and ketamine infusion
干预措施: Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992 (Drug)
结局指标
主要结局
Evaluation of effectiveness of lidocaine-ketamine infusions: PQAS-R
时间窗: 4 weeks after the first infusion and every 4 weeks up to 36 weeks
Primary outcome measure: relative change on the PQAS-R. Moderate clinically important improvement is considered as 30% reduction (Dworkin et al., 2008)
次要结局
- Effect of lidocaine and ketamine infusion on BDI(Baseline to end-of-study every 4 weeks up to 36 weeks)
- Effect of lidocaine and ketamine infusion on PGIC(Baseline to end-of-study every 4 weeks up to 36 weeks)
- Effect of lidocaine and ketamine infusion on BPI(Baseline to end-of-study every 4 weeks up to 36 weeks)
- Effect of lidocaine and ketamine infusion on PQAS-R(Baseline to end-of-study every 4 weeks up to 36 weeks)
- Effect of lidocaine and ketamine infusion on PSEQ(Baseline to end-of-study every 4 weeks up to 36 weeks)
- Effect of lidocaine and ketamine infusion on PCS(Baseline to end-of-study every 4 weeks up to 36 weeks)
- Effect of lidocaine and ketamine infusion on PSPDE(Baseline to end-of-study every 4 weeks up to 36 weeks)
- Effect of lidocaine and ketamine on narcotic consumption(Baseline to end-of-study up to 36 weeks)