Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Not Applicable

• Conditions: Cervical Spine Degeneration
• Interventions: Drug: Normal saline; Drug: Nefopam 20 mg/ml

• Registration Number: NCT03955705
• Lead Sponsor: Mahidol University

Brief 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-07
• Study Start: 2019-05-15
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline solution	Normal saline	Normal saline or 0.9% Sodium Chloride (NaCl) or NSS
Nefopam	Nefopam 20 mg/ml	Nefopam: 20 mg (infuse at least 15 minutes) every 4-6 hours, max 120 mg/day

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	24 hours	Intravenous morphine was given to all by patient controlled analgesia (PCA) machine. The higher morphine consumption reflects higher postoperative pain.

Secondary Outcome Measures

Name	Time	Method
The change in Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score)	30 days	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
The change in pain scores	72 hours	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.

Trial Locations

Locations (1)

Siriraj Hospital Mahidol University; 🇹🇭 Bangkok, Thailand