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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Yonsei University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: February 27, 2013
Last updated: February 17, 2014
Last verified: February 2014

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 Intervention
Lumbar Spinal Stenisis or Lumbar Herniated Intervertebral Disc
Drug: nefopam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 54
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01808014

Contact: Tae Dong Kweon, MD 82-2228-82428

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

Responsible Party: Yonsei University Identifier: NCT01808014     History of Changes
Other Study ID Numbers: 4-2012-0920
Study First Received: February 27, 2013
Last Updated: February 17, 2014

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

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on May 24, 2017