Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Analgesic Effect of Nefopam on the Fentanyl Based PCA (Patient-controlled Analgesia) After Lumbar Spinal Surgery

NCT01808014

Lumbar Spinal Stenisis or Lumbar Herniated Intervertebral Disc

UNKNOWN NA

Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

NCT04241640

Pain, Postoperative

COMPLETED PHASE4

Effects of Nefopam on Hyperalgesia After Cardiac Surgery

NCT00413257

Hyperalgesia Pain, Postoperative Pain, Chronic Disease

COMPLETED PHASE2/PHASE3

Effectiveness of Nefopam for Thermoregulation During Surgery

NCT03122665

Hypothermia

COMPLETED NA

Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy

NCT02577068

Thyroidectomy Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Spine Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nefopam

Nefopam: 20 mg (infuse at least 15 minutes) every 4-6 hours, max 120 mg/day

Group Type EXPERIMENTAL

Nefopam 20 mg/ml

Intervention Type DRUG

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 saline solution

Normal saline or 0.9% Sodium Chloride (NaCl) or NSS

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

0.9% Sodium chloride (normal saline or NSS)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nefopam 20 mg/ml

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.

Intervention Type DRUG

Normal saline

0.9% Sodium chloride (normal saline or NSS)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Acupan 0.9% NaCl or NSS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes