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Completed

NCT Number: NCT04241640

Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

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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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

faculty of medicine Siriraj hospital

Bangkok, 10600, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nefopam 20 MG/ML

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. morphine consumption in first 24 hours post-operative

    Time frame: 24 hours

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

Secondary outcomes

  1. numeric pain score

    Time frame: 24 hours

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

  2. side effect of nefopam

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 27, 2020
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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