MedPath

Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

Phase 4
Completed
Conditions
Pain, Postoperative
Interventions
Registration Number
NCT04241640
Lead Sponsor
Mahidol University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
72
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Nefopam group[Nefopam 20 MG/ML-
placebo groupPlacebo-
Primary Outcome Measures
NameTimeMethod
morphine consumption in first 24 hours post-operative24 hours

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

Secondary Outcome Measures
NameTimeMethod
numeric pain score24 hours

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

side effect of nefopam24 hours

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

Trial Locations

Locations (1)

faculty of medicine Siriraj hospital

🇹🇭

Bangkok, Thailand

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