Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nefopam
Nefopam: 20 mg (infuse at least 15 minutes) every 4-6 hours, max 120 mg/day
干预措施: Nefopam 20 mg/ml (Drug)
Normal saline solution
Normal saline or 0.9% Sodium Chloride (NaCl) or NSS
干预措施: Normal saline (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: 24 hours
Intravenous morphine was given to all by patient controlled analgesia (PCA) machine. The higher morphine consumption reflects higher postoperative pain.
次要结局
- The change in Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score)(30 days)
- The change in pain scores(72 hours)