Efficacy of Duloxetine analgesia after large intestine removal

Phase 4

Recruiting

• Conditions: Intestinal Neoplasms, Diverticular disease of intestine, Postoperative Pain; C04.588.274.476.411; C23.550.767.700

• Registration Number: RBR-5jzmqq
• Lead Sponsor: niversidade Federal de Santa Catarina

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)