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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Nefopam 80mg/day; Drug: Normal saline

• Registration Number: NCT04450355
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-29
• Study Start: 2020-07-30
• Primary Completion: 2021-08-09
• Study Completion: 2021-11-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nefopam group	Nefopam 80mg/day	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.
Control group	Normal saline	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 at the end of surgery.

Primary Outcome Measures

Name	Time	Method
Total fentanyl consumption during 24 hours	postoperative 24 hours	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Secondary Outcome Measures

Name	Time	Method
Total fentanyl consumption	postoperative 48 hours	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Postoperative pain score	postoperative 24, 48 hours	11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
Postoperative nausea and vomiting	postoperative 24, 48 hours	Incidence of postoperative nausea and vomiting (%)
chronic postsurgical pain	3-months after surgery	Incidence of chronic postsurgical pain (NRS ≥ 3) (%)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of