Clinical trial

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

Name

SI 001/2020

Description

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.

Trial arms

Trial start

2020-09-01

Estimated PCD

2022-08-01

Trial end

2023-03-01

Status

Completed

Phase

Early phase I

Treatment

Nefopam 20 MG/ML

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

Arms:

Nefopam group[

Placebo

Arms:

placebo group

Size

Primary endpoint

morphine consumption in first 24 hours post-operative

24 hours

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}

Updated at

2023-06-29

1 organization

1 product

1 drug

2 indications

Organization

Product

Indication

Indication

Drug