Efficacy of Duloxetine analgesia after large intestine removal

INTERVENTION: Analgesia Colectomy Drug Duloxetine Hydrochloride Participants will be allocated into two blinded groups. Randomization will be performed by an independent investigator, researcher responsible for the research, who will not participate in anesthesia, surgical procedure or data collection. Sixty patients scheduled for colectomy will be recruited and allocated into two groups of 30 participants by computer randomized allocation based on random number generation. Patients will be randomly assigned to either group to receive duloxetine or placebo. The drugs will be provided in envelopes as identical capsules to ensure study blinding. According to the assigned study group, patients will receive placebo (cornstarch‐containing capsule) or duloxetine 60 mg 2 hours before the surgical procedure and the same medication 24 hours after the procedure. The capsule will be administered orally with a small drink of water by a research assistant not involved in the study. Patients will be instructed before the surgical procedure by a professional linked to the anesthesiology service of the HU‐UFSC on the use of the static and dynamic Visual Analog Pain Scale (VAS), by supporting the trunk in a supine position for 5 seconds, and about the management of the Patient Controlled Analgesia (PCA) device postoperatively through a standard audiovisual (video) feature. The anesthetic technique will be standardized in both groups and will be performed by the anesthesiology service team of HU‐UFSC. Preoperatively, 2 hours before surgery, patients will receive 1 oral pill (duloxetine 60mg or placebo made from cornstarch) with a small sip of water. The patient and the surgical team will be blinded to the study intervention. Induction of general anesthesia will be performed with propofol 2 mg / kg, fentanyl 1.5‐2 mcg / kg and atracurium 0 Postoperative Care CONDITION: Diverticular disease of intestine Intestinal Neoplasms Intestinal Neoplasms, Diverticular disease of intestine, Postoperative Pain ; Intestinal Neoplasms ; Diverticular disease of intestine ; Pain, Postoperative Pain, Postoperative PRIMARY OUTCOME: Evaluate the consumption of morphine using a patient‐controlled analgesia pump during the 1st and 2nd postoperative days, to be verified by Mann‐Whitney U test or Student t test, depending on the normality of the data, in patients undergoing open abdominal colectomy under general anesthesia who will receive duloxetine or placebo in the perioperative period (2 hours before and 24 hours after the procedure) ; INCLUSION CRITERIA: ASA I, II and III patients; aged 18 to 85 years; of both sexes; who underwent open elective colectomy under general anesthesia and allow the use of their data for research activities by signing their Informed Consent Terms (ICF). SECONDARY OUTCOME: It is expected to find a greater degree of satisfaction in relation to postoperative analgesia in the duloxetine group in relation to the placebo, through the Revised American Pain Society Patient Outcome Questionnaire for Quality Improvement of Pain Management in Hospitalized Adults, containing 12 items, to be verified by Mann‐Whitney U test or Student t test, depending on the normality of the data It is expected to find a higher incidence of side effects (sedation, itching, drowsiness, headache, dizziness, nausea and vomiting, visual disturbances and dry mouth) in the postoperative period of the duloxetine group in relation to the placebo, to be verified by the exact test of Fisher It is expected to find less impact and time to be able to return to work in the postoperative period of the duloxetine group in relation to the placebo, computed according to the time of medical statement required by the patient, to be verified by Mann‐Whitney U test or Student t, depending on the normality of the data It is expected to find lower pain scores on the visual analogue scale in the postoperative period of the duloxetine group compared to placebo, to be verified by Mann‐Whitney U test or Student t test, depending on the normality of the data