Study of the Effects of Nefopam on Hyperalgesia Following Sternotomy in Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Nociceptive threshold evaluated with Von Frey mechanical dynamic stimulation. This will start 10cm far from the wound on a perpendicular line to the wound and will be conducted by 1cm step to the wound until the patient explains the stimulation
研究概览
简要总结
Postoperative pain after major surgery is consecutive not only to the nociceptive inputs coming from the surgical lesion, but also to peripheral and central neuronal sensitization. This lead to postoperative hyperalgesia and allodynia that are enhanced by the per operative use of high opioid doses. Anti-NMDA drugs have been reported as able to reduce this sensitization process and then to decrease acute morphine tolerance during the postoperative period. Nefopam has been lately shown to combine in experimental trials analgesic and anti hyperalgesic effects. The aim of this study is to compare anti-hyperalgesic effects of nefopam given either before incision and continuously for the following 48hours or starting from the end of the surgery and given for 48hours to a control group that would receive placebo for 48hours. Postoperative analgesia will be based on morphine PCA. Pain scores, hyperalgesia, allodynia, postoperative morphine consumption, and development of chronic pain will be the main criteria that will be evaluated during this study
详细描述
Introduction :
Postoperative pain is not only a consequence of the surgical lesion, but is also related to sensitization processes that appear in peripheral and central nerves. This sensitization induce clinically hyperalgesia and allodynia. From an experimental viewpoint it comes mainly from a central activation of NMDA receptors in neurons that conduct the nociceptive message.
Recent studies have shown that high-dose opioids were able, via NMDA receptors, to enhance postoperative hyperalgesia and to increase pain scores and morphine consumption after surgery. Nevertheless per operative use of opioid is still necessary to avoid per operative stress and systemic consequence of the surgical stimulation.
Some drugs (ketamine, nitrous oxide...) succeeded in reducing postoperative hyperalgesia and pains scores and acute morphine tolerance. They also were able to decrease pain chronicization.
Nefopam, well known as an analgesic since the 80's, presents both analgesic and anti hyperalgesic properties as lately demonstrated in experimental trials. Nevertheless these anti hyperalgesic properties have never been evaluated in humans scheduled for cardiac surgery. Nefopam administration could reduce acute morphine tolerance and could enhance postoperative pain management by reducing sensitization processes and hyperalgesia.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55-75 years old
- •ASA score: 1-3
- •Patients scheduled for Cardiac surgery with median sternotomy for : single valve replacement or Bentall or Benson or Tyron David surgery, single or multiple Cardiac Artery Bypass Grafting (CABG) , combined surgery (valve replacement + CABG) without preoperative risk of postoperative complications
- •Informed consent obtained from the patient
排除标准
- •Drug or alcohol abuse history
- •Analgesic or opioid consumption within the 12hs preceding the surgery
- •Chronic use of analgesic drugs or history of chronic pain
- •Convulsion or epilepsy history
- •Glaucoma history
- •Disability to understand morphine PCA use
- •Allergy to nefopam
研究组 & 干预措施
1
nefopam infusion will start before the surgical incision, at the induction time of anesthesia and will be continued until postoperative H48
干预措施: Nefopam (Drug)
2
nefopam administration will start at the end of the surgery and will be continued until postoperative H48
干预措施: néfopam (Drug)
3
control group that will receive a placebo from the induction time of anesthesia until H48
干预措施: Placebo comparator (Drug)
结局指标
主要结局
Nociceptive threshold evaluated with Von Frey mechanical dynamic stimulation. This will start 10cm far from the wound on a perpendicular line to the wound and will be conducted by 1cm step to the wound until the patient explains the stimulation
时间窗: H 24
次要结局
- static hyperalgesia with Von Frey stimulation 1cm far from the middle of the wound, on the right side of the wound.(1, 2, 4 and 7 days after intervention)
- Morphine consumption(over the 48 H postoperative)
- Pain scores evaluation(Acute pain (1, 2, 4 and 7 days after intervention) / Chronic Pain (3, 6 and 12 month))
- Cognitive functions evaluation(1, 2, 4 and 7 days after intervention)