Postoperative Pain
Conditions
Brief 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.
Interventions
DRUGPregabalin 150mg
Preemptive use of pregabalin 150 mg starting three days before surgery up to the third postoperative day
DRUGPlacebo oral tablet
Preemptive use of Placebo oral tablet starting three days before surgery up to the third postoperative day
Sponsors
InCor Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Partial pressure of carbon dioxide in millimeter of mercury (mmHg) | 03 hours, 06 hours, 12 hours and 24 hours post operative |
| 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 |
| 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 |
| 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 |
| 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 |
| Partial pressure of oxygen in millimeter of mercury (mmHg) | 03 hours, 06 hours, 12 hours and 24 hours post operative |
Countries
Brazil
Contacts
Primary ContactBruno R Barbosa, MD
Outcome results
None listed