Lumbar Spinal Stenisis or Lumbar Herniated Intervertebral Disc Clinical Trial
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment