NCT04173390

PREemptive Analgesia With preGABAlin in HEART Surgery

Preemptive Analgesia With Pregabalin in Heart Surgery: a Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: InCor Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Pregabalin 150mg	Preemptive use of pregabalin 150 mg starting three days before surgery up to the third postoperative day
DRUG	Placebo oral tablet	Preemptive use of Placebo oral tablet starting three days before surgery up to the third postoperative day

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-12-31
• Completion: 2023-11-01
• First posted: 2019-11-21
• Last updated: 2021-02-23

Locations

2 sites across 1 country: Brazil