NCT03955705

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

May 7, 2019

Last Update Submit

September 2, 2020

Conditions

Cervical Spine Degeneration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The change in Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score)

    30 days

  • The change in pain scores

    72 hours

Study Arms (2)

Nefopam

EXPERIMENTAL

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

Drug: Nefopam 20 mg/ml

Normal saline solution

PLACEBO COMPARATOR

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

Drug: Normal saline

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.

Also known as: Acupan
Nefopam
Normal salineDRUG

0.9% Sodium chloride (normal saline or NSS)

Also known as: 0.9% NaCl or NSS
Normal saline solution

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (5)

  • Rao R. Neck pain, cervical radiculopathy, and cervical myelopathy: pathophysiology, natural history, and clinical evaluation. J Bone Joint Surg Am. 2002 Oct;84(10):1872-81. doi: 10.2106/00004623-200210000-00021. No abstract available.

    PMID: 12377921BACKGROUND

  • Dordoni PL, Della Ventura M, Stefanelli A, Iannace E, Paparella P, Rocca B, Accorra F. Effect of ketorolac, ketoprofen and nefopam on platelet function. Anaesthesia. 1994 Dec;49(12):1046-9. doi: 10.1111/j.1365-2044.1994.tb04352.x.

    PMID: 7864317BACKGROUND

  • Sunshine A, Laska E. Nefopam and morphine in man. Clin Pharmacol Ther. 1975 Nov;18(5 Pt 1):530-4. doi: 10.1002/cpt1975185part1530.

    PMID: 1102231BACKGROUND

  • Kim KH, Abdi S. Rediscovery of nefopam for the treatment of neuropathic pain. Korean J Pain. 2014 Apr;27(2):103-11. doi: 10.3344/kjp.2014.27.2.103. Epub 2014 Mar 28.

    PMID: 24748937RESULT

  • Martinez V, Beloeil H, Marret E, Fletcher D, Ravaud P, Trinquart L. Non-opioid analgesics in adults after major surgery: systematic review with network meta-analysis of randomized trials. Br J Anaesth. 2017 Jan;118(1):22-31. doi: 10.1093/bja/aew391.

    PMID: 28039239RESULT

MeSH Terms

Interventions

NefopamSaline Solution

Intervention Hierarchy (Ancestors)

OxazocinesAzocinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Manee Raksakietisak, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 20, 2019

Study Start

May 15, 2019

Primary Completion

April 30, 2021

Study Completion

May 31, 2021

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)