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| Name | Class |
|---|---|
| Pharmbio Korea | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nefopam group | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nefopam 80mg/day | Drug | continuous nefopam infusion |
| |
| Normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| Total fentanyl consumption during 24 hours | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia | postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total fentanyl consumption | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia | 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" |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | KS013 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16368814 | Background | 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. doi: 10.1213/01.ANE.0000181103.07170.15. | |
| 14633755 | Background |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009340 | Nefopam |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010079 | Oxazocines |
| D001392 | Azocines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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A prospective randomized double-blinded study
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Outcomes assessor not involved in this study will investigate the outcomes. The patient will be not informed of the infusion of nefopam by not attaching an identifiable label so that it cannot be distinguished from normal saline.
| Drug |
continuous normal saline infusion |
|
| postoperative 24, 48 hours |
| Postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting (%) | postoperative 24, 48 hours |
| chronic postsurgical pain | Incidence of chronic postsurgical pain (NRS ≥ 3) (%) | 3-months after surgery |
| 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. doi: 10.1093/bja/aeg264. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |