跳至主要内容
临床试验/NCT01808014
NCT01808014Unknown不适用

The Analgesic Effect of Nefopam on the Fentanyl Based PCA (Patient-controlled Analgesia) After Lumbar Spinal Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
54
试验地点
1
主要终点
The additional analgesic effect of nefopam on the fentanyl based PCA after lumbar spinal surgery

研究概览

简要总结

Posterior lumbar spinal surgical pain leads to a severe degree of pain, and, hence, various means of pain management are required. Opioid pain medications such as morphine and fentanyl are frequently used as intravenously administered medications. To reduce the use of opioids for pain relief, a non-opioid form of pain relief, such as a Non-Steroidal Anti-Inflammatory Drug (NSAID), is often added to the regimen.

With the use of NSAIDs, however, the risk of systemic side effects such as bleeding, gastroduodenal bleeding, and kidney damage are being reported, and there is also a report of inhibition of spinal fusion; these risks limit the use of NSAIDs.

Nefopam, a new centrally-acting analgesic agent, has been reported in an animal study to desensitize post-surgical pain, and when used with an opioid analgesic, it indirectly controlled the NMDA receptor, which inhibited the generation of c-fos gene at the spine. There are also reports that Nefopam managed pain by inhibiting the serotonin reuptake receptors.

In clinical practice, the administration of Nefopam in patients who required post-surgical pain management reduced the use of opioid analgesics by 20-50 % and also reduced the prevalence of nausea and vomiting.

Therefore, the investigators considered whether the addition of Nefopam for intravenous patient-controlled analgesia in patients with lumbar spinal surgery would reduce the side effects seen in monotherapy with opioid analgesia and result in effective pain management. This study was conducted to address this question.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

The addition of Nefopam

Experimental

The addition of Nefopam for intravenous patient-controlled analgesia in patients with lumbar spinal surgery would reduce the side effects seen in monotherapy with opioid analgesia and result in effective pain management.

干预措施: nefopam (Drug)

结局指标

主要结局

The additional analgesic effect of nefopam on the fentanyl based PCA after lumbar spinal surgery

时间窗: up to 48 hours post-surgery

The resting visual analogue scale (r-VAS) and cough visual analogue scale (c-VAS) were measured.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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