Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

Sponsor

Mahidol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04241640

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

numeric pain score [24 hours]
numeric pain score in 1, 2, 12, 24 hours after surgery
side effect of nefopam [24 hours]
side effect of nefopam: tachycardia, sweating, nausea, vomiting, sedation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of medicine Siriraj hospital	Bangkok		Thailand	10600

Sponsors and Collaborators

Mahidol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chaowanan Khamtuikrua, Principal Investigator, Mahidol University

ClinicalTrials.gov Identifier:

NCT04241640

Other Study ID Numbers:

SI 001/2020

First Posted:

Jan 27, 2020

Last Update Posted:

Apr 7, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pain, Postoperative

Nefopam

Study Results

No Results Posted as of Apr 7, 2022