Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Study Overview
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Brief Summary
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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
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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).

Official Title
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Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Conditions
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Cervical Spine Degeneration

Intervention / Treatment
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* Drug: Nefopam 20 mg/ml
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nefopam<br>Nefopam: 20 mg (infuse at least 15 minutes) every 4-6 hours, max 120 mg/day | Drug: Nefopam 20 mg/ml<br>* 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.<br>* Other names: Acupan;|
| Placebo Comparator: Normal saline solution<br>Normal saline or 0.9% Sodium Chloride (NaCl) or NSS | Drug: Normal saline<br>* 0.9% Sodium chloride (normal saline or NSS)<br>* Other names: 0.9% NaCl or NSS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption | Intravenous morphine was given to all by patient controlled analgesia (PCA) machine. The higher morphine consumption reflects higher postoperative pain. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score) | Changes in NPSI-T (minimum 0- maximum 100) period by recording NPSI-T at preoperative period, compared with postoperative day 1, 3, 15,30. The total score is 100, the higher scores reflect higher neuropathic pain | 30 days | 
| The change in pain scores | Changes in pain scores (minimum 0- maximum 10) at different time point 0 (upon arrival to recovery room), postoperative at 4, 8, 12, 16, 24, 48, 72 hours. The higher scores reflect higher pain. | 72 hours |