Nefopam for Post Video-Assisted Thoracoscopic Lobectomy
1 other identifier
interventional
72
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2020
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedNovember 20, 2024
June 1, 2023
1.9 years
January 23, 2020
November 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
morphine consumption in first 24 hours post-operative
morphine consumption record from patient-controlled analgesia machine in 24 hours post-operative
24 hours
Secondary Outcomes (2)
numeric pain score
24 hours
side effect of nefopam
24 hours
Study Arms (2)
Nefopam group[
EXPERIMENTALplacebo group
PLACEBO COMPARATORInterventions
Nefopam group nefopam 20 mg during surgery and follow by 80 mg in 24 hours postoperative
Eligibility Criteria
You may qualify if:
- Schedule to video-assisted thoracoscopic surgery : VATs lobectomy
- Can operate a patient-controlled analgesia (PCA) device
- No contraindication for nefopam
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
faculty of medicine Siriraj hospital
Bangkok, 10600, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 23, 2020
First Posted
January 27, 2020
Study Start
September 1, 2020
Primary Completion
August 1, 2022
Study Completion
March 1, 2023
Last Updated
November 20, 2024
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share