Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT04241640
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 28, 2020
Sponsor:
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

Layout table for study information
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
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.


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

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 ClinicalTrials.gov identifier (NCT number): NCT04241640


Contacts
Layout table for location contacts
Contact: Chaowanan Khamtuikrua, MD +6624197990 ext 113 ckhamtuicrua@gmail.com
Contact: Sirilak Suksompong, MD +6624197990 ext 113 ssuksompong5@gmail.com

Locations
Layout table for location information
Thailand
faculty of medicine Siriraj hospital
Bangkok, Thailand, 10600
Contact: Chaowanan Khamtuikrua, MD    +6624197990 ext 113    Ckhamtuicrua@gmail.com   
Contact: Sirilak Suksompong, MD    +6624197990 ext 113    ssuksompong5@gmail.com   
Sponsors and Collaborators
Mahidol University
Layout table for additonal information
Responsible Party: Chaowanan Khamtuikrua, Principal Investigator, Mahidol University
ClinicalTrials.gov 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

Layout table for additional information
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:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Nefopam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs