Study design and data anlalysis
This is a prospective cohort study performed in a tertiary level referral center for minimally invasive gynecological surgery. All women who were referred to our center and met the inclusion criteria between January 2020 and April 2021 were enrolled.
Inclusion criteria were: women scheduled for laparoscopic surgery for benign
gynecological conditions such as ovarian cyst (simple cyst, endometrioma, dermoid cyst), hydro/sactosalpinx, ectopic pregnancy, primary/secondary infertility, patient carrier of BRCA mutation and aged more than 18 years old. All women gave their written informed consent to participate in the study. Exclusion criteria were contraindications to GA o RA, including American Society of Anesthesiologists Physical Status Classification System (ASA score) IV, suspected malignancy, and BMI > 30 kg/m2.
Exclusion criteria to RA were patient’s refusal, infection at the site of injection, coagulopathy (acquired, induced, genetic), allergy to local anesthetics, patients with suspected malignancy, uncooperative patient for psychiatrics and neurological disorders (such as dementia and psychosis), increased intracranial pressure.
During the preoperative workup, all patients underwent gynecological examination and a detailed pelvic ultrasound scan was performed by an expert sonographer, eventually, MRI was performed to accurately define the characteristics of the lesion. Women were invited to participate in the study during the preoperative examination. After detailed and extensive counseling by the surgeon as well as by two anesthesiologists (AC and GG), with expertise about anesthesia in laparoscopic surgery and clinical and practical implication of both GA and RA, informed written consent was obtained and patient were allocated to one of the two groups according to their preferences.
Seventy patients were initially analyzed, but 66 patients satisfied the inclusion criteria and were enrolled in the study: 36 in Group A, 30 in Group B.
All the procedures were performed by a single operator (PG) with expertise in laparoscopic gynecological surgery who performed more than 100 procedures per year. The entire procedure was performed so that the patient could be invited to follow the entire procedure. A high-resolution color video screen was provided to show the intraoperative images. In group A, patients were informed about every single step of the intervention by both the surgeon and anesthesiologist. During each phase, patients were asked to score the pain using a Likert scale from 1 to 5.
Baseline demographic and clinical data of the patients included in the study as well as the intra-operative surgical and anestesiologic variables were recorded.
Postoperative pain assessed through Visual analog scale (VAS) was the primary outcome. The main secondary outcomes included: postoperative nausea and vomiting (PONV) and antiemetic/analgesic drugs usage. Further secondary outcomes were anesthesia complications, resumption of bowel motility, time to mobilization, global surgeons and patient satisfaction, length of hospital stay, intraoperative pain in RA group through Likert scale.