Intestinal Neoplasms, Diverticular disease of intestine, Postoperative Pain
Conditions
Interventions
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,
Drug
E03.091
E04.210.219
Sponsors
Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
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).
Exclusion criteria
Exclusion criteria: Patients under 18 and over 85; patients with renal or hepatic impairment; history of drug or alcohol abuse; history of chronic pain or daily opioid intake; ASA IV patients; urgency / emergency surgical procedure; pregnancy or puerperal period; history of psychiatric illness, cognitive disorders and / or seizures; history of use of analgesics and / or medications with central nervous system effects within three days prior to surgery; known allergy to duloxetine or other compositions used in the study; coagulopathies; uncooperative, legally incapable or contraindicated patients to perform any proposed procedure; or refusal to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;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 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 | — |
Countries
Brazil
Contacts
Public ContactThomas Erdmann
Universidade Federal de Santa Catarina
Outcome results
None listed