Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Intensity of Pain
研究概览
简要总结
Prescription drug abuse represents a major healthcare problem, with treatment costs reaching billions of dollars annually in the United States alone. Today opioids are commonly prescribed for chronic non-cancer pain and are only partially effective for short-term pain relief. Whereas opioids are initially part of the solution for pain, it eventually often turns to be a problem in patient with chronic pain. Long-term treatment with opioids can be complicated by development of tolerance, dependency, addiction, abnormal pain sensitivity, hormonal changes, and immune modulation. Unfortunately, the chronic use of anti-inflammatory drugs is associated with a marked increase in adverse effects.
The purpose of this study is to determine whether systemic administration of lidocaine provides effective pain relief in opioid dependent chronic pain patients. Investigators intend to demonstrate that lidocaine infusion can improve pain relief and physical function in opioid dependent patients, thus improving compliance and patient satisfaction, which may potentially help wean patients off narcotics. The long-term goal of this proposal is to decrease opioid dependence in chronic pain patients by using lidocaine infusion.
详细描述
There is a significant disconnect between the escalating healthcare problem of opioid use for chronic pain, and the development of novel therapeutic strategies. A plausible strategy is to interrupt the vicious cycle of pain, inflammation and hyperesthesia is using highly efficacious non-opioid drugs that do not require chronic administration, such as lidocaine. Lidocaine is FDA approved local anesthetic, class 2 antiarrhythmic with analgesic, antihyperalgesic and anti-inflammatory properties without rewarding and addictive properties. Intravenous lidocaine has been utilized since 1943 for a large spectrum of pain conditions. Lidocaine also has been shown to significantly reduce circulating inflammatory cytokines production. Investigators propose that systemic administration of lidocaine will decrease the intensity, duration of pain in opioid dependent chronic pain patients. The long-term goal of this proposal is to decrease opioid dependence in chronic pain patients by using lidocaine infusion. The central hypothesis is that lidocaine infusion decreases the intensity of pain in opioid dependent chronic pain patients.
Primary outcome: To determine the short-term effect of lidocaine infusion on the intensity of pain in opioid dependent chronic pain patients.
Secondary outcome1: Determine the duration of pain relief after lidocaine infusion in opioid dependent chronic pain patients. Investigators hypothesize that lidocaine infusions will have a long lasting Visual Analog Pain (VAS) score improvement that will extend beyond the time of infusion.
This intermediate and long-term pain relief will be demonstrated by measuring both VAS pain scores 3 times a day for 3 weeks and by the reduction in daily opioid use by 25%.
Secondary outcome2: Determine the effect of lidocaine infusion on opioid induced hyperalgesia. Lidocaine infusion may decrease cytokine levels both acutely after infusion as compared to baseline, as well as at the end of 1 week after infusion.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old -Patient currently on stable dose of opioids for more than six months period -
- •Patients with Chronic uncontrolled neuropathic pain with documented pain score > or = 4 despite opioids
- •Not currently abusing opioids or other illicit drugs as demonstrated by history and negative urine toxicology screen
- •Patient agrees to come to all follow up visits at 1, 2, and 3 week following infusion
- •Having baseline/screening EKG
排除标准
- •Individuals meeting DSM-V dependence criteria for alcohol, benzodiazepine, CNS stimulant, marijuana or other drug of abuse.
- •Hepatic dysfunction as determined by history and physical or clinical significant lab.
- •Cardiac arrhythmias including heart block and QT prolongation as determined by history or baseline EKG.
- •Subject has inability to understand and cooperate with study procedures or provide informed consent.
- •Subject has history of intolerance or allergic reaction to lidocaine.
- •Subject has history of seizures.
- •Raynaud's disease
- •Renal impairment as determined by clinically significant labs.
- •Women of childbearing age who either have:
- •A positive pregnancy test
- •Unprotected heterosexual sex since their previous menses or;
- •Not currently using and/or willing to use a medically approved form of contraception (e.g., birth control pill).
研究组 & 干预措施
Lidocaine infusion
A continuous intravenous infusion of lidocaine
干预措施: Lidocaine infusion (Drug)
Saline infusion
A continuous intravenous infusion of saline
干预措施: Saline infusion (Drug)
结局指标
主要结局
Intensity of Pain
时间窗: Immediately after continuous 4-hours Intravenous lidocaine infusion
Visual Analog Pain Scores on a scale of 0 to 10 (0=no pain and 10=worst pain)
次要结局
- Withdrawal Time (Seconds)(Immediately after Lidocaine Infusion)
研究者
Enas Kandil
Asistant Professor
University of Texas Southwestern Medical Center