Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Mahidol University50 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cervical Spine Degeneration

Interventions

Nefopam 20 mg/mlDRUG

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.

Normal salineDRUG

0.9% Sodium chloride (normal saline or NSS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Siriraj Hospital Mahidol University

Bangkok, Thailand

Outcomes

Primary Outcomes

Total morphine consumption

Intravenous morphine was given to all by patient controlled analgesia (PCA) machine. The higher morphine consumption reflects higher postoperative pain.

Time frame: 24 hours

Secondary Outcomes

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

Time frame: 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.

Time frame: 72 hours

Data from ClinicalTrials.gov

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