Effect of nefopam- versus fentanyl-based patient-controlled analgesia on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: a prospective double-blind randomized controlled trial.

OBJECTIVE

This study comparatively evaluated the effect of patient-controlled analgesia (PCA) regimens using equipotent doses of nefopam or fentanyl during laparoscopic gynecological surgery on postoperative nausea and vomiting (PONV).

RESEARCH DESIGN AND METHODS

Patients undergoing gynecological laparoscopic surgery were randomly allocated to receive either nefopam- (non-opioid; N group) or fentanyl-based (F group) PCA. PONV and postoperative pain were assessed during the 72 hours following discharge from the post-anesthetic care unit (PACU). The adverse effects of nefopam were also evaluated.

CLINICAL TRIAL REGISTRATION

Cris.nih.go.kr ID KCT0000783.

RESULTS

In total, 94 patients were included in the final analysis. The PONV incidence and scale and the Rhodes index scores were significantly lower in the N group than the F group at all measured times. The N group exhibited a significantly lower incidence of PONV (15/47 [31.9%] vs. 27/47 [57.4%], respectively; P = 0.022) and severity of PONV (0 [1] vs. 1 [2], respectively; P = 0.005) 24 hours after PACU discharge and a significantly lower Rhodes index score (0 [3] vs. 5 [9], respectively; P = 0.002) from 30 minutes after PACU arrival to 24 hours after PACU discharge than did the F group. There was no significant difference in postoperative pain at any time between the two groups. Dry mouth on PACU arrival was significantly more frequent in the N group. However, the frequency of dry mouth decreased after PACU arrival in the N group, resulting in a significantly lower incidence 24 hours after PACU discharge.

CONCLUSIONS

Use of a PCA regimen with nefopam for analgesia was associated with a similar degree of pain control and superior PONV outcomes 24 hours after PACU discharge and no adverse events compared with a PCA regimen using an equipotent dose of fentanyl.