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.