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

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ClinicalTrials.gov Identifier: NCT01808014
Recruitment Status : Unknown
Verified February 2014 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : March 8, 2013
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.


Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenisis or Lumbar Herniated Intervertebral Disc Drug: nefopam Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: The addition of Nefopam
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.
Drug: nefopam
The chief investigator prepared the medications according to the selected randomized table, and investigators who were not involved in medication preparation recorded the pain and prevalence of complications in study subjects. The double-blind restriction was lifted if the patient withdrew from the study, and the next patient was classified into a group while blinded by using the randomized table.Intramuscular midazolam 0.05 mg/kg was administered as a premedication, and then a blood pressure machine, electrocardiogram, and pulse oximeter were connected to the patient in the operating room.



Primary Outcome Measures :
  1. The additional analgesic effect of nefopam on the fentanyl based PCA after lumbar spinal surgery [ Time Frame: up to 48 hours post-surgery ]
    The resting visual analogue scale (r-VAS) and cough visual analogue scale (c-VAS) were measured.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808014


Contacts
Contact: Tae Dong Kweon, MD 82-2228-82428 YSANES71@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Tae Dong Kweon, MD         
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01808014     History of Changes
Other Study ID Numbers: 4-2012-0920
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Yonsei University:
nefopam, spinal surgery, postoperative pain control

Additional relevant MeSH terms:
Nefopam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs