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Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

Nefopam for Post Video-Assisted Thoracoscopic Lobectomy Pain Management and the Improvement of Enhanced Recovery After Surgery (ERAS): a Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04241640
Enrollment
72
Registered
2020-01-27
Start date
2020-09-01
Completion date
2023-03-01
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

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

DRUGPlacebo

Placebo

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
morphine consumption in first 24 hours post-operative24 hoursmorphine consumption record from patient-controlled analgesia machine in 24 hours post-operative

Secondary

MeasureTime frameDescription
numeric pain score24 hoursnumeric pain score in 1, 2, 12, 24 hours after surgery
side effect of nefopam24 hoursside effect of nefopam: tachycardia, sweating, nausea, vomiting, sedation

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026