PREemptive Analgesia With preGABAlin in HEART Surgery (PREGABA-HEART)

University of São Paulo (USP)

Status and phase

Unknown

Phase 2

Conditions

Postoperative Pain

Treatments

Drug: Pregabalin 150mg

Drug: Placebo oral tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT04173390

SDC DT 023/19/122

17907319.5.0000.8069 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

230 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who will undergo median sternotomy due to the need for cardiac surgery (valvular or myocardial revascularization);
Patients between 18 and 70 years old;
Patients able to swallow tablets and agree to participate in this clinical trial.

Exclusion criteria

Patients with chronic renal failure with creatinine clearance less than or equal to 30 mL/min;
Patients with known hypersensitivity to pregabalin;
Hemodynamically unstable patients using vasoactive drugs the day before surgery;
Unconscious and/or sedated patients, or without cognitive discernment to use the visual analog scale;
Patients previously submitted to sternotomy; emergency surgery;
Patients with neurological diseases; anticonvulsant drug users.