Strength and limitations
Although we are fully aware that no other studies like randomized
controlled trials can minimize bias and provide a rigorous tool to
examine cause-effect relationships between intervention and outcome, our
study was conceived and designed as a prospective study. We believe,
indeed, that patient’s motivation and willingness to accomplish surgery
under RA are key aspects for the accomplishment of the procedure
therefore, in our opinion, randomization of patients at the moment has
to be considered counterintuitive and challenging.
Strengths of our study were the sample size (the largest reported so far
in literature), the accomplishment of all the procedures by one skilled
surgeon and the assessment of the tolerability and the evaluation of the
pain during each step of laparoscopy (in order to determine the
acceptability of the procedure when performed under regional
anesthesia). We consider this latter of paramount importance based on
the assumption that sedation should be avoided as much as possible to
preserve spontaneous breathing already restricted by the level of
neuraxial anesthesia and Trendelenburg’s position.