Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nefopam group[

Group Type EXPERIMENTAL

Nefopam 20 MG/ML

Intervention Type DRUG

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

placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Nefopam 20 MG/ML

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes