Nefopam as a Multimodal Analgesia for Thoracic Surgery

Lung Cancer Clinical Trial

Official title:

Nefopam as a Multimodal Analgesia for Video-assisted Thoracoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05173337
• Other study ID #: NEVATS2
• Status: Completed
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: September 23, 2022

Study information

• Verified date: February 2023
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute postoperative pain after video-assisted thoracoscopic surgery is very severe. Because pain after thoracic surgery prevents early recovery, and increases postoperative complications, its is important to prevent pain after video-assisted thoracoscopic surgery. In the present study, we will evaluate whether nefopam reduces pain after video-assisted thoracoscopic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 23, 2022
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient scheduled for elective video-assisted thoracoscopic surgery

• American Society of Anesthesiologists physical grade I, II, III

• patient aged from 18 years old

Exclusion Criteria:

• history of allergy in nonsteroidal anti-inflammatory drugs, or nefopam

• renal insufficiency

• liver insufficiency

• myocardial infarction

• glaucoma

• pregnant and lactating women at the time of surgery

• patient who did not consent to the use of patient-controlled analgesia

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Drug:
• Nefopam
Nefopam 20 mg is mixed to 100 mL of normal saline, and is infused intravenously over 15 minutes. 20 mg of nefopam is administered intravenously for two times, after induction and at the end of surgery.

Locations

Country	Name	City	State
Korea, Republic of	Eunah Cho	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain after 1 hour of surgery	Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).	1 hour after surgery.
Primary	Pain after 6 hour of surgery	Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).	6 hours hours after surgery.
Primary	Pain after 12 hour of surgery	Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).	12 hours after surgery.
Primary	Pain after 24 hour of surgery	Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).	24 hours after surgery.
Secondary	Patient-controlled analgesia use	Fentanyl consumption administered thorough the patient-controlled analgesia machine.	24 hours after surgery
Secondary	Rescue analgesics	Additional analgesic use during postoperative period.	24 hours after surgery.