Ignite Creation Date:
2024-05-06 @ 1:25 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01808014
Status:
UNKNOWN
Last Update Posted:
2014-02-19
First Post:
2013-02-27
Brief Title:
The Analgesic Effect of Nefopam on the Fentanyl Based PCA Patient-controlled Analgesia After Lumbar Spinal Surgery
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2014-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None