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

NCT01808014 | Unknown DMC

• 1 other identifier: 4-2012-0920
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenisis or Lumbar Herniated Intervertebral Disc

Keywords

nefopam, spinal surgery, postoperative pain control

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

The addition of Nefopam

EXPERIMENTAL

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

Interventions

nefopam DRUG

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.

The addition of Nefopam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Nefopam

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Tae Dong Kweon, MD

CONTACT

82-2228-82428; YSANES71@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 8, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

KR (1)