The Efficacy of Low Dose Nefopam Combined with Fentanyl Injection for Controlling Immediate Postoperative Pain After Laparoscopic Surgery. A Double-blinded, Randomized Controlled Trial

Abstract

Backgroud: Despite the widespread use of laparoscopic surgery across various procedures, effective postoperative pain management remains a challenge. Nefopam may be effective as an adjuvant analgesic for acute postoperative pain control. Objective: This study highlights the analgesic effects and risk of adverse events when using a low dose nefopam for laparoscopic surgical procedures. Methods: This study is double-blinded, prospective randomized controlled trial. There were 50 subjects who were divided into 2 groups. The nefopam group (n=25) received slow intravenous (IV) injection of 10 mg nefopam and IV 25 mcg fentanyl immediately in post-anesthetic care unit (PACU), while the placebo group (n=25) received IV isotonic saline and IV 25 mcg fentanyl. The primary outcomes include the numerical rating scales (NRS) of postoperative pain intensity, fentanyl consumption, adverse effects and patient satisfaction in PACU. Results: There was no difference in demographic data between groups. The NRS scores of the nefopam group at 30, 45 and 60 minutes postoperative were significantly lower than of the placebo group (p ˂ 0.05). The amount of fentanyl consumption in PACU is comparable between groups (p = 0.311). Patients in both groups experienced some adverse effects including nausea, vomiting, tachycardia, dry mouth, and dizziness, however the incidence was not different between groups. Additionally, the nefopam group tended to have better patient satisfaction. Conclusion: The additional low dose nefopam administered by slow IV injection could reduce acute pain intensity after laparoscopic abdominal surgery, while this approach did not increase the risk of adverse effects.