Fentanyl Ultra Low Doses Effects on Human Volunteer's Nociceptive Threshold. Towards a Simple Pharmacological Test Able to Predict Pain Vulnerability, Post Operative Hyperalgesia Development Risk?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Nociceptive threshold evaluated with sternal electronical Von Frey mechanical stimulation. The stimulation will increase until the volunteer presses a trigger when the stimulation becomes painful.
研究概览
简要总结
Exaggerated pain and hyperalgesia are major issues after surgery and can lead to chronic pain. Opioid are parts of pain sensitization processes but remain absolutely necessary in the intraoperative period. NMDA receptor antagonists succeed in reducing this pain sensitization process. Recent studies show that in pain and opioid-experienced rats (POER) fentanyl ultra low doses do not induce analgesia, as observed in naive rats, but hyperalgesia. This is the first demonstration that a drug can induce opposite effect depending on individual history. We also observed a strong correlation between this hyperalgesic response in POER and the intensity of hyperalgesia they develop later, after inflammatory or surgical pain. The main aim of this study is to measure the dose effect response to fentanyl "ultra low doses" on human volunteer's nociceptive threshold, to determine if such an opposite response profile can be revealed.
详细描述
- Principal Objective : "Evaluate fentanyl "ultra low doses" effects on human volunteer's nociceptive threshold depending on their prior pain and opioid experience."
- Secondary Objective : "Confirm the innocuousness of this test (the 3 "ultra low doses" used in this trial will be 10 to 1,000 fold lower than low doses use for anesthesia and analgesia) and to find the fentanyl ultra low dose that could be used to develop a pain sensitisation predictive test."
- Study design : Bicentric, prospective, randomized, double-blind study.
Inclusion criteria :
In both groups:
- 18-40 years old male volunteer
- weight: 60 to 85 kg
- ASA score: 1
- Informed consent obtained from the patient
- Gender : Male
In "operated" group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •In both groups:
- •18-40 years old male volunteer
- •Weight: 60 to 85 kg
- •ASA score: 1
- •Informed consent obtained from the patient
- •In "operated" group:
- •At least one history of peripheral surgery under general anesthesia with opioid in the past five years.
排除标准
- •In both groups:
- •The patients do not accept inclusion to the study
- •Drug or alcohol abuse history
- •Chronic use of analgesic drugs or history of chronic pain
- •Analgesic or opioid consumption within the 12hs preceding the fentanyl or placebo injection
- •Neurological and/or psychiatric disorder, inability to give informed consent
- •Psychological trauma within the two year preceding the inclusion
- •Any contraindication to fentanyl use
- •Use of any medication interacting with fentanyl
- •Exclusion period from the national healthy volunteer register
- •In "healthy" group:
- •Any history of general anesthesia or surgery
研究组 & 干预措施
2
0,05 µg/kg
干预措施: Fentanyl/Placebo injection (Drug)
1
0,5 µg/kg
干预措施: Fentanyl/Placebo injection (Drug)
3
0,005 µg/kg
干预措施: Fentanyl/Placebo injection (Drug)
4
NaCl 0,9 %
干预措施: Fentanyl/Placebo injection (Drug)
结局指标
主要结局
Nociceptive threshold evaluated with sternal electronical Von Frey mechanical stimulation. The stimulation will increase until the volunteer presses a trigger when the stimulation becomes painful.
时间窗: 5 min after injection, and every 15 min during 1 hour
次要结局
- Non invasive blood pressure (SBP, DBP), heart rate, respiratory rate, pulse oxymetry and cognitive functions evaluation (sedation score).(all along the experimentation)