Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Nefopam 20 MG/ML; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04241640

SI 001/2020

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Nefopam group[

Experimental group

Treatment:

Drug: Nefopam 20 MG/ML

placebo group

Placebo Comparator group

Treatment:

Drug: Placebo