Memantine for Post-Operative Pain Control
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in numerical ratings on pain diaries as outpatients (pre and post surgery)
研究概览
简要总结
Pain is a common element of surgery. Opiates (morphine, oxycodone, hydrocodone, methadone, fentanyl) are very helpful in decreasing pain after surgery. Unfortunately, with repeated use opiates lose their effectiveness, such that patients need to utilize more opiates to achieve adequate pain relief - a phenomenon called tolerance. Sometimes tolerance to a pain reliever's effects can develop in just a few hours. It is thought that activation of the N-methyl d-aspartate (NMDA) receptor, a "switch" found on the surface of nerves, is partially responsible for opiate tolerance. Memantine is a medication that limits the activity of NMDA receptors in the brain and spinal cord. It has been used for years to help patients with Alzheimer's Disease. In this study, we will study the effects of memantine when combined with opiate medications to see whether it can increase the effectiveness of opiates for pain after surgery and reduce the side effects caused by opiates (e.g., sedation, nausea, itching).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery for total hip replacement, knee replacement OR lumbar spinal fusion
- •Taking no opiate medication OR taking opiate medication for at least 6 weeks
排除标准
- •History of alcohol or drug abuse
- •Clinical diagnosis of Alzheimer's Disease
- •Prior adverse reaction to memantine
- •Severe renal impairment (creatinine clearance <30 ml/min)
- •Inability to give informed consent
研究组 & 干预措施
Opiate Naive
Subjects who have not taken opiate medication in previous 6 weeks before surgery
干预措施: Memantine (Drug)
Opiate Naive
Subjects who have not taken opiate medication in previous 6 weeks before surgery
干预措施: Placebo (Drug)
Opiate tolerant
Subjects who have taken opiate medications for the 6 weeks before surgery
干预措施: Memantine (Drug)
Opiate tolerant
Subjects who have taken opiate medications for the 6 weeks before surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Change in numerical ratings on pain diaries as outpatients (pre and post surgery)
时间窗: For 1 week pre-surgery, through 2 weeks post-surgery
Daily pain numerical ratings at rest and with movement as inpatients.
时间窗: Immediately post-surgery until discharge (2-3 days)
Total opiate dose via patient controlled IV hydromorphone
时间窗: Post-surgery day 1
Oxycodone dose taken prn
时间窗: Post-surgery day 2 through 3 months.
次要结局
- Treatment group differences in side effects (nausea, itching, sedation, urinary retention following foley catheter discontinuation)(One week pre-surgery through 3 months post-surgery)
- Changes in cognitive function, assessed with Digit-Symbol Substitution Test and Trail Making Test B(One week pre-surgery, immediately pre-surgery, and post-surgery days 1, 2, 3)
- Changes in pain and quality of life questionnaire responses (SF-McGill-2, Brief Pain Questionnaire, SF-36 v2)(One week pre-surgery through 3 months post-surgery, particularly as outpatient)