The Analgesic Efficacy of Nefopam in Patient-Controlled Analgesia after Laparoscopic Gynecologic Surgery: A Randomized, Double-Blind, Non-Inferiority Study

Abstract

Opioid-sparing effects of nefopam during patient-controlled analgesia (PCA) are well demonstrated. We hypothesized that postoperative pain control with an opioid-equivalent dose of nefopam as a single analgesic agent for PCA would not be inferior to fentanyl in laparoscopic gynecologic surgery. In total, 135 patients were randomly assigned to the N (nefopam 200 mg), NF (fentanyl 500 mcg + nefopam 100 mg), and F (fentanyl 1000 mcg) groups (n = 45 patients per group). The primary outcome was the numerical rating scale (NRS) score at rest at 6 h postoperatively, and the non-inferiority limit was set to 1. Secondary outcomes were pain severity and incidence of nausea and vomiting for 48 h postoperatively. Mean differences (MD) in primary outcome between the N and F groups were 0.4 (95% confidence interval (CI) −0.5 to 1.3). The upper limit of 95% CI exceeded the non-inferiority limit. The N group showed higher pain scores than the NF group (MD, 1.1; 95% CI, 0.3–1.9) in pairwise comparisons. No significant intergroup differences were observed in the cumulative dose of PCA usage and incidence of postoperative nausea and vomiting (PONV). In laparoscopic gynecological surgery, nefopam alone showed limited efficacy for postoperative pain control.

Comparison of Nefopam-Based Patient-Controlled Analgesia with Opioid-Based Patient-Controlled Analgesia for Postoperative Pain Management in Immediate Breast Reconstruction Surgery: A Randomized Controlled Trial

“…These results were consistent with previous studies, demonstrating the effectiveness of nefopam, whether used as an adjuvant or as a substitute for opioids in PCA, for achieving effective and comparable pain control after surgery [ 6 , 7 , 8 , 9 , 10 ]. Kim et al reported that nefopam alone provided sufficient analgesic effect following cardiac surgery.…”

“…Previous studies have yielded conflicting results regarding PONV incidence when using nefopam as a postoperative analgesic. Some studies have suggested that nefopam itself may not decrease PONV [ 6 , 7 , 8 , 13 ] due to its emetic properties [ 14 , 15 ]. However, others have reported that nefopam use could reduce opioid consumption, thereby reducing PONV incidence [ 9 , 10 ].…”

“…The side-effects associated with nefopam include nausea, dizziness, headache, dry mouth, sweating, and tachycardia [ 5 , 14 , 20 ]. Previous studies have indicated that these side-effects are not severe when nefopam is administered at appropriate doses [ 6 , 7 , 9 , 10 ]. Neurological complications, such as delirium, confusion, and seizures, are more commonly observed in older patients or those with pre-existing psychological disorders.…”

“…Nefopam is a non-opioid analgesic that acts centrally by inhibiting serotonin, norepinephrine, and dopamine reuptake and modulating glutaminergic transmission via N-methyl-D-aspartate receptors [ 4 , 5 ]. Previous studies have shown that PCA, including nefopam, either alone or combined with opioids, offers comparable postoperative pain relief with significantly reduced opioid consumption and associated complications compared to PCA with opioids alone [ 6 , 7 , 8 , 9 , 10 ]. However, there is a lack of studies focused specifically on nefopam’s analgesic efficacy as an adjuvant or primary agent in PCA for patients undergoing BRS.…”

Prevention of postoperative nausea and vomiting after orthognathic surgery: a scoping review

“…Capsicum plaster at classical Chinese acupoints is an alternative to acupuncture, which has been reported to be an effective method for reducing postoperative pain and PONV when applied to the acupuncture points [ 36 ]. Nefopam is a non-opioid, non-steroidal centrally acting analgesic that has been used as an alternative to opioids to control mild to moderate pain [ 37 ]. Nefopam was shown to provide similar postoperative analgesia to ketorolac when used as an adjuvant analgesic with fentanyl-based PCA [ 38 ].…”