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.
| Status | Recruiting |
| Enrollment | 54 |
| Est. completion date | June 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
A. Inclusion criteria: The study subjects were adult patients, 20-65 years old, who were
going to have spinal fusion surgery due to conditions such as spinal stenosis or disks and
who fell under the American Society of Anesthesiologist physical status classifications of
1 or 2. B. Exclusion criteria: Patients who could not read or understand the consent documents or who had a defect in blood coagulation, hepatectomy, pneumonectomy, nephrectomy, cardiovascular disease, administration of MAO inhibitor, ischuria, glaucoma, or a history of seizure were excluded from the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The additional analgesic effect of nefopam on the fentanyl based PCA after lumbar spinal surgery | The resting visual analogue scale (r-VAS) and cough visual analogue scale (c-VAS) were measured. | up to 48 hours post-surgery | No |