drugset / Trial / NCT04173390

PREemptive Analgesia With preGABAlin in HEART Surgery

NCT04173390

Phase 2 Unknown 230 enrolled InCor Heart Institute
RandomizedParallel-groupTriple-blindTreatment

Summary

BACKGROUND: Postoperative pain after cardiac surgery has high incidence and is associated with worse morbidity. Pregabalin is a new antiepileptic drug used in patients with chronic pain and has been studied even more in postoperative. OBJECTIVE: Evaluate whether preemptive pregabalin use compared with placebo decreases pain perception in patients undergoing cardiac surgery in the first 24 hours and 2 months after hospital discharge; evaluate analgesic consumption in the immediate postoperative period; evaluate differences in blood gas parameters between groups; evaluate anesthetic recovery by QoR-40; assess incidence of serious adverse events (reintubation and mental confusion); incidence of delirium through the CAM-ICU questionnaire; assess adverse drug events (nausea, vomiting, pharmacodermia, allergic reactions). METHOD: Randomized, triple-blind, placebo-controlled clinical trial. EXPECTED RESULTS: Postoperative pain control with a drug that could cause fewer side effects, may lead to faster clinical improvement, fewer medications and fewer procedures, and lower healthcare costs with a decrease in intensive care unit (ICU) stay.

Timeline

Start
2021-03-01
Primary completion
2021-12-31
Completion
2023-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 150 mg

Indications

No indication recorded.