RESULTS
All selected patients underwent surgical laparoscopy under regional (Group A) or general (Group B) anesthesia.
Baseline demographic and clinical data of the patients included in the study did not show significant differences between the two groups (Table 1 ).
Among the gynecological benign diseases, most of the patients had a simple ovarian cyst (43/66, 65.2%) in particular among Group B (26/30, 86.7%). No patient who underwent general anesthesia had sterility, ectopic pregnancy or BRCA1/2 mutation as surgical indication. Considering the type of intervention, although a statistically significant difference emerged between the two groups, this difference was not clinically relevant. No patients required laparotomic or anesthesia conversion and in no case accessory ports, in addition to the conventional four scheduled, were needed.
The degree of Trendelenburg’s position was similar in the groups: 16.3±3 in Group A vs. 16.7±2.8 degrees in Group B (p=0.609). Also, operative time was not significantly different between the two groups (58.2±24.8 in group A vs. 65±24.4 minutes in group B, p=0.267).
Regarding the postoperative pain (Table 2 ), the VAS score showed a change from 0 to 24 hours (h): indeed, it was significantly lower in Group A up to 6 h [0 (0-0.8) vs 2 (1-5)], p<0.001 in the immediate postoperative period and (1.5 (0-2.8) vs 3 (1-5), p 0.004 at 6 h) with an inversion at 18 h (2 (0.2-5.2) vs 0.5 (0-3), p 0.02) for Group B, and no statistically significant differences between the two groups at 24 h. Figure 1 reports the VAS score trend during the observation time (0 to 24 h). Analyzing the intake of analgesics after surgery, no differences were observed among the type of analgesic (paracetamol, ketorolac and tramadol) and during the post-operative observation time, except for paracetamol at 0 h, with a significant difference between the two groups (0 (0) vs 6 (20), (p=0.007).In Table 3 are reported the secondary outcomes such as anesthesia related complications, resumption of bowel motility, patient’s mobilization, surgeons global satisfaction (the surgical team at the end of the procedure was asked about global satisfaction in term of pelvic organ exposure and ability to perform the procedure in relation to the anesthesia used), patient satisfaction (patients were asked to answer a closed-ended question upon discharge: would you do the same anesthesia again?), length in hospital stay. A faster resumption of bowel motility (7.1+ 1.1 vs 13+ 1.2, p <0.001) and patient’s mobilization (2.9+ 0.6 vs 6.7+ 1.4, p <0.001) and an early discharge (17.9+1.4 vs 23.8+ 1.8, p <0.001) were observed in Group A compared to Group B . No significant difference were recorded in term of PONV.
Concerning anesthetic complications, we registered two cases of intraoperative hypotension (one for each group), managed with intravenous saline infusion, and only one case of bradycardia in group A. Two post-operative complications were recorded (according to Clavien-Dindo Classification I): one urinary tract infection (Group A) and one urinary retention (Group B) resolved with intermittent catheterization.
Finally, we reported for Group A the pain score obtained with the Likert scale, classically divided into 5 points (0: no pain, 5: maximum pain) during the various stages of surgery: introduction of uterine manipulator, introduction Hasson trocar and induction of pneumoperitoneum; introduction of ancillary trocars; exploration of pelvic organs; actual surgical procedure; skin suture. As reported inTable 4 , all patients showed a pain score of 1 or 2, with only 3 cases (7.9%) with a score of 3 during the skin suture.