Laparoscopic versus open myomectomy: a double-blind study to evaluate postoperative pain.

The advantages of laparoscopic over open surgery have been documented in nonblinded settings. Our prospective, double-blind setting evaluated pain scores 72 h after surgery by comparing patients who underwent laparoscopic myomectomy or with laparotomy. Forty women referred for conservative myomectomy were included in the study. After stratification (myoma size, number of myomas, and surgeon), patients were randomized to either laparoscopy (n = 19) or laparotomy (n = 21) and received a standardized anesthesia and patient-controlled analgesia for 24 h after surgery. Identical wound dressings were applied to blind the patient and the observer to the surgical approach. The postoperative pain scores were documented on a visual analog scale (VAS; 0 = no and 10 = unbearable pain) at 24, 48, and 72 h after surgery. As the primary outcome variable, we calculated the mean overall VAS-score at these time points. P < 0.05 (t-test and analysis of covariance) was considered statistically significant. There were no differences in patient characteristics among the groups. The mean overall VAS score at 24, 48, and 72 h was statistically significantly lower in the laparoscopic group compared with the laparotomy group (2.28 +/- 1.38 versus 4.03 +/- 1.63; P < 0.01). Our data demonstrate, for the first time in a double-blind setting, that laparoscopic myomectomy reduces postoperative pain for 72 h after surgery compared with laparotomy.

RCT Entities:   Population Interventions Outcomes