NCT03955705

Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Nefopam is a benzoxazocine derivative which is non-opioid and non NSAIDs. The previous studies showed that nefopam can inhibit reuptake of serotonin, norepinephrine and dopamine. It has no respiratory depression so may be useful in potential airway compromized surgery like anterior cervical discectomy and fusion (ACDF). This study aims to study the analgesic properties of nefopam after ACDF.

Detailed description

The investigators enroll 50 patient who admitted for ACDF. Standard general anesthesia will be performed in all of the patients. Then, an hour before finishing operation, the patients will be divided into two groups. The first group will receive Nefopam 20 mg infuse for 60 min. The another group or group NSS will receive the same amount of 0.9% sodium chloride. The recorded data include patient demographic data, intraoperative blood loss, hemodynamics and pre and postoperative pain scores and Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score).

Conditions

• Cervical Spine Degeneration

Interventions

Type	Name	Description
DRUG	Nefopam 20 mg/ml	Nefopam is a benzoxazocine derivative which is non-opioid and non NSAIDs. The previous studies showed that nefopam can inhibit reuptake of serotonin, norepinephrine and dopamine.
DRUG	Normal saline	0.9% Sodium chloride (normal saline or NSS)

Timeline

• Start date: 2019-05-15
• Primary completion: 2021-04-30
• Completion: 2021-05-31
• First posted: 2019-05-20
• Last updated: 2020-09-04

Locations

1 site across 1 country: Thailand