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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01808014
First received: February 27, 2013
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01808014     History of Changes
Other Study ID Numbers: 4-2012-0920
Study First Received: February 27, 2013
Last Updated: February 17, 2014
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Intervertebral Disk Displacement
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Nefopam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014