Back to resultsNefopam for Post Video-Assisted Thoracoscopic Lobectomy
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Nefopam 20 MG/ML
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Schedule to video-assisted thoracoscopic surgery : VATs lobectomy
- Can operate a patient-controlled analgesia (PCA) device
- No contraindication for nefopam
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
Sites / Locations
- faculty of medicine Siriraj hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nefopam group[
placebo group
Arm Description
Outcomes
Primary Outcome Measures
morphine consumption in first 24 hours post-operative
morphine consumption record from patient-controlled analgesia machine in 24 hours post-operative
Secondary Outcome Measures
numeric pain score
numeric pain score in 1, 2, 12, 24 hours after surgery
side effect of nefopam
side effect of nefopam: tachycardia, sweating, nausea, vomiting, sedation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04241640
Brief Title
Nefopam for Post Video-Assisted Thoracoscopic Lobectomy
Official Title
Nefopam for Post Video-Assisted Thoracoscopic Lobectomy Pain Management and the Improvement of Enhanced Recovery After Surgery (ERAS): A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nefopam group[
Arm Type
Experimental
Arm Title
placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nefopam 20 MG/ML
Intervention Description
Nefopam group nefopam 20 mg during surgery and follow by 80 mg in 24 hours postoperative
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
morphine consumption in first 24 hours post-operative
Description
morphine consumption record from patient-controlled analgesia machine in 24 hours post-operative
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
numeric pain score
Description
numeric pain score in 1, 2, 12, 24 hours after surgery
Time Frame
24 hours
Title
side effect of nefopam
Description
side effect of nefopam: tachycardia, sweating, nausea, vomiting, sedation
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Schedule to video-assisted thoracoscopic surgery : VATs lobectomy
Can operate a patient-controlled analgesia (PCA) device
No contraindication for nefopam
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
Facility Information:
Facility Name
faculty of medicine Siriraj hospital
City
Bangkok
ZIP/Postal Code
10600
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
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Nefopam for Post Video-Assisted Thoracoscopic Lobectomy
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