An interventional study of Nefopam 80mg/day and Normal saline in Postoperative Pain, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 90 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
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.
Drug: Nefopam 80mg/day
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.
Drug: Normal saline
continuous nefopam infusion
continuous normal saline infusion
Total fentanyl consumption during 24 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Time frame: postoperative 24 hours
Total fentanyl consumption
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Time frame: postoperative 48 hours
Postoperative pain score
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
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (%)
Time frame: postoperative 24, 48 hours
chronic postsurgical pain
Incidence of chronic postsurgical pain (NRS ≥ 3) (%)
Time frame: 3-months after surgery
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital