Seoul National University Hospital
Seoul, KS013, South Korea
NCT Number: NCT04450355
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.
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Notify Me19 year–70 year
All sexes
Interventional
Not applicable
Seoul, KS013, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
continuous nefopam infusion
continuous normal saline infusion
Time frame: postoperative 24 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Time frame: postoperative 48 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Time frame: postoperative 24, 48 hours
11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
Time frame: postoperative 24, 48 hours
Incidence of postoperative nausea and vomiting (%)
Time frame: 3-months after surgery
Incidence of chronic postsurgical pain (NRS ≥ 3) (%)
Seoul National University Hospital
Other
Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After Video Assisted Thoracic Surgery: A Double Blind Randomized Controlled Trial
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