PREemptive Analgesia With preGABAlin in HEART Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Pregabalin 150mg
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pregabalin<br> | Drug: Pregabalin 150mg<br>* Preemptive use of pregabalin 150 mg starting three days before surgery up to the third postoperative day<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo oral tablet<br>* Preemptive use of Placebo oral tablet starting three days before surgery up to the third postoperative day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception in visual analog scale (0 means no pain and 10 is the most severe pain) at 72 hour post operative |  | 72 hours post operative | 
| Analgesic opioids consumption at 72 hours post operative |  | 72 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception in visual analog scale (0 means no pain and 10 is the most severe pain) and analgesic opioids consumption at month 2 post operative |  | Month 2 post operative | 
| Partial pressure of oxygen in millimeter of mercury (mmHg) |  | 03 hours, 06 hours, 12 hours and 24 hours post operative | 
| Partial pressure of carbon dioxide in millimeter of mercury (mmHg) |  | 03 hours, 06 hours, 12 hours and 24 hours post operative | 
| Arterial blood potential of hydrogen (pH) |  | 03 hours, 06 hours, 12 hours and 24 hours post operative | 
| Oxygen saturation in percentage (%) |  | 03 hours, 06 hours, 12 hours and 24 hours post operative | 
| Anesthetic recovery by Quality of Recovery 40-item questionnaire (QoR-40 - 40 items questionnaire each item ranging from 1 to 5 being 1 very poor and 5 excellent) |  | 24 hour post operative | 
| Incidence of serious adverse events (reintubation, infection, bleeding, AKI) |  | 72 hour post operative | 
| Incidence of delirium by Confusion Assessed Method fo the Intensive Care Unity (CAM-ICU) |  | 24 hour post operative | 
| Number of participants with treatment-related adverse drug events (nausea, vomiting, pharmacodermia, allergic reactions) assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0) |  | 72 hour post operative |