Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Occurrence of Opioid-induced hyperalgesia (OIH)
研究概览
简要总结
The purpose of this study is to evaluate whether using ultra-low dose naloxone, an opioid antagonist, has the potential to block remifentanil-induced hyperalgesia and tolerance following surgery.
There are 3 study groups: (1) low dose remifentanil (LO, 0.1 micrograms/kg/mL), (2) high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL), or (3) high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
The hypothesis of the study is that occurrence of remifentanil-induced hyperalgesia (low score in mechanical pain threshold) in the HN group will be lower than in the HI group.
详细描述
Purpose:
Opioid antagonists at ultra-low doses have been used with opioid agonists to prevent or limit opioid tolerance. Remifentanil, a rapid onset/offset opioid that is often used as an anesthesia adjunct intraoperatively, has been associated with the development of hyperalgesia and opioid tolerance postoperatively. Opioid-induced hyperalgesia (OIH) induced by remifentanil intraoperatively may be a factor contributing to an increase in postoperative pain as well as difficulty in controlling such pain. The purpose of this study will be to evaluate whether an ultra-low dose of naloxone, an opioid antagonist, could block remifentanil-induced hyperalgesia and tolerance following surgery.
This research will help elucidate the degree of OIH after surgeries involving remifentanil and determine if a new technique can be employed to decrease remifentanil-induced OIH. By mitigating OIH, patients should have a decrease in postoperative pain and an increase in patient satisfaction at UCI and other hospitals where such a technique is employed.
There are 3 study groups: (1) low dose remifentanil (LO, 0.1 micrograms/kg/mL), (2) high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL), or (3) high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Background:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who provide written informed consent.
- •Age 18 years old or older (no upper age limit for inclusion)
- •Gender: male or female.
- •Surgery: Posterior spinal fusions
排除标准
- •Allergy to opiates
- •Chronic pain other than the primary indication for surgery
- •Psychiatric illness
- •History of substance abuse problem including alcohol &/or cannabis
- •BMI > 35
- •Subjects under 18 years of age.
- •Subject without the capacity to give written informed consent.
- •Female subjects who are pregnant
研究组 & 干预措施
LO-low dose remifentanil
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
干预措施: Remifentanil (Drug)
HN-high dose remifentanil with ultra-low dose naloxone
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
干预措施: Remifentanil +ultra-low dose naloxone (Drug)
HI-high dose remifentanil with placebo
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
干预措施: Remifentanil+ Placebo (Drug)
结局指标
主要结局
Occurrence of Opioid-induced hyperalgesia (OIH)
时间窗: 48 hr Post-surgery
Mechanical Pain Threshold-determined by von Frey filaments around the incision site
次要结局
- Opioid consumption(48 hrs post surgery)
- Cold Pressure Test(48 hrs post surgery)
- Visual Analog Scale (VAS) Pain scores(Baseline)
- McGill short form questionnaire(Baseline)
- Brief Pain Inventory(Baseline)
研究者
Ariana M. Nelson
Associate Clinical Professor
University of California, Irvine