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Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04241640
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 28, 2020
Information provided by (Responsible Party):
Chaowanan Khamtuikrua, 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Nefopam 20 MG/ML Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nefopam for Post Video-Assisted Thoracoscopic Lobectomy Pain Management and the Improvement of Enhanced Recovery After Surgery (ERAS): A Randomized Controlled Trial
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Experimental: Nefopam group[ Drug: Nefopam 20 MG/ML
Nefopam group nefopam 20 mg during surgery and follow by 80 mg in 24 hours postoperative

Placebo Comparator: placebo group Drug: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04241640

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Contact: Chaowanan Khamtuikrua, MD +6624197990 ext 113
Contact: Sirilak Suksompong, MD +6624197990 ext 113

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faculty of medicine Siriraj hospital
Bangkok, Thailand, 10600
Contact: Chaowanan Khamtuikrua, MD    +6624197990 ext 113   
Contact: Sirilak Suksompong, MD    +6624197990 ext 113   
Sponsors and Collaborators
Mahidol University
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Responsible Party: Chaowanan Khamtuikrua, Principal Investigator, Mahidol University Identifier: NCT04241640    
Other Study ID Numbers: SI 001/2020
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs