Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Mahidol University

Status: Unknown

Conditions: Cervical Spine Degeneration

Treatments: Drug: Normal saline; Drug: Nefopam 20 mg/ml

Study type: Interventional

Funder types: Other

Identifiers

NCT03955705

Si204/2019

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with cervical spondylosis or cervical spondylotic myelopathy undergoing elective anterior cervical spine surgery such as ACDF or anterior cervical corpectomy and fusion (ACCF)
• American Society of Anesthesiologists (ASA) class I-III
• Age 18-75 years old
• Body weight > 50 kg, BMI < 30 kg/m2

Exclusion criteria

• Convulsion or seizure
• Myocardial ischemia or infarction
• Risk of urinary retention from urethral disease or prostate disease
• Angle closure glaucoma
• Patients on monoamine oxidase inhibitor
• Psychiatric patients
• Pregnant or lactated woman
• Creatinine clearance < 30 ml/min
• Allergic to nefopam
• Patients on pregabaline or gabapentin
• Poorly controlled hypertension
• Cannot understand or do the questionnaire of Thai version of Neuropathic pain symptom inventory (NPSI-T) score

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Nefopam

Experimental group

Description:

Nefopam: 20 mg (infuse at least 15 minutes) every 4-6 hours, max 120 mg/day

Treatment:

Drug: Nefopam 20 mg/ml

Normal saline solution

Placebo Comparator group

Description:

Normal saline or 0.9% Sodium Chloride (NaCl) or NSS

Treatment:

Drug: Normal saline