CClinicalTrials.gg
CompletedNCT04241640Updated Nov 20, 2024

Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

A Phase 4 interventional study of Nefopam 20 MG/ML and Placebo in Pain, Postoperative, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by Mahidol University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Video-assisted thoracoscopic (VATs) lobectomy is mild to moderately pain procedure. For conventional thoracotomy, there are many invasive pain control such as epidural analgesia, paravertebral block. However, for VATs, the invasive pain control somehow are too invasive. Nefopam is non-opioid painkilling medication, Serotonin, norepinephrine, dopamine reuptake inhibitor. Many study were demonstrated positive outcome of nefopam usage in many operation such as abdominal surgery, laparocopic surgery, orthopedic surgery. Nevertheless, nefopam for VATs is not well studied yet.

02

Conditions studied

  • Pain, Postoperative

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 72 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Schedule to video-assisted thoracoscopic surgery : VATs lobectomy
  • Can operate a patient-controlled analgesia (PCA) device
  • No contraindication for nefopam

Exclusion criteria

Exclusion Criteria:

  • Epilepsy, on monoamine oxidase (MAO) inhibitors, glaucoma
  • Creatinine clearance \< 60 ml/min
  • Liver disease: child-pugh score B or C
  • Allergy to nefopam
  • Chronic opioid use
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Nefopam group[

    Drug: Nefopam 20 MG/ML

  • Placebo comparator
    placebo group

    Drug: Placebo

Interventions

  • DrugNefopam 20 MG/ML

    Nefopam group nefopam 20 mg during surgery and follow by 80 mg in 24 hours postoperative

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. morphine consumption in first 24 hours post-operative

    morphine consumption record from patient-controlled analgesia machine in 24 hours post-operative

    Time frame: 24 hours

Secondary outcomes

  1. numeric pain score

    numeric pain score in 1, 2, 12, 24 hours after surgery

    Time frame: 24 hours

  2. side effect of nefopam

    side effect of nefopam: tachycardia, sweating, nausea, vomiting, sedation

    Time frame: 24 hours

07

Study locations

1 site
  • faculty of medicine Siriraj hospital
    Bangkok, 10600, Thailand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04241640
Lead sponsor
Mahidol University
Responsible party
Chaowanan Khamtuikrua (Principal Investigator, Mahidol University) — Principal investigator
First posted
Jan 27, 2020
Start date
Sep 1, 2020
Primary completion
Aug 1, 2022
Completion
Mar 1, 2023
Last update
Nov 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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