UnknownNot Applicable

Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Thailand50 participantsStarted 2019-05-15

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total morphine consumption

Timeframe: 24 hours

Trial details

NCT IDNCT03955705

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-30

View on ClinicalTrials.gov More Cervical Spine Degeneration trials