Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After VATS

Postoperative Pain Clinical Trial

Official title:

Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After Video Assisted Thoracic Surgery: A Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450355
• Other study ID #: 2001-036-1092
• Status: Completed
• Phase: N/A
• Start date: July 30, 2020
• Est. completion date: November 10, 2021

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the continuous infusion of intravenous nefopam in patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the continuous infusion of intravenous nefopam can significantly reduce postoperative opioid consumption and pain severity in patients with VATS.

Description:

Adult patients undergoing elective unilateral VATS segmentectomy or lobectomy are randomly allocated to receive continuous nefopam infusion (n=45) or not (n=45), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA). At the end of induction, the nefopam group will receive intravenous nefopam 20mg mixed with 50ml of normal saline, and at the end of surgery this group will receive intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr. The control group will receive intravenous normal saline 50ml at the end of induction and receive intravenous normal saline 50ml at a rate of 2ml/hr.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 10, 2021
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy under general anesthesia

• American Society of Anesthesiologists (ASA) physical classification I-II

• Consent to IV-patient controlled analgesia use

• Willingness and ability to sign an informed consent document

Exclusion Criteria:

• Do not understand our study

• Allergies to anesthetic or analgesic medications

• Continuous local anesthetics infiltration for postoperative pain control

• Patients who receive mechanical ventilation more than 2 hours after surgery

• Pregnancy/Breast feeder

• Medical or psychological disease that can affect the treatment response

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Nefopam 80mg/day
continuous nefopam infusion
• Normal saline
continuous normal saline infusion

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Pharmbio Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Du Manoir B, Aubrun F, Langlois M, Le Guern ME, Alquier C, Chauvin M, Fletcher D. Randomized prospective study of the analgesic effect of nefopam after orthopaedic surgery. Br J Anaesth. 2003 Dec;91(6):836-41. — View Citation

Tirault M, Derrode N, Clevenot D, Rolland D, Fletcher D, Debaene B. The effect of nefopam on morphine overconsumption induced by large-dose remifentanil during propofol anesthesia for major abdominal surgery. Anesth Analg. 2006 Jan;102(1):110-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total fentanyl consumption during 24 hours	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia	postoperative 24 hours
Secondary	Total fentanyl consumption	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia	postoperative 48 hours
Secondary	Postoperative pain score	11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"	postoperative 24, 48 hours
Secondary	Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting (%)	postoperative 24, 48 hours
Secondary	chronic postsurgical pain	Incidence of chronic postsurgical pain (NRS = 3) (%)	3-months after surgery