Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241640
• Other study ID #: SI 001/2020
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: June 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Nefopam 20 MG/ML
Nefopam group nefopam 20 mg during surgery and follow by 80 mg in 24 hours postoperative
• Placebo
Placebo

Locations

Country	Name	City	State
Thailand	faculty of medicine Siriraj hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption in first 24 hours post-operative	morphine consumption record from patient-controlled analgesia machine in 24 hours post-operative	24 hours
Secondary	numeric pain score	numeric pain score in 1, 2, 12, 24 hours after surgery	24 hours
Secondary	side effect of nefopam	side effect of nefopam: tachycardia, sweating, nausea, vomiting, sedation	24 hours