Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 17907319.5.0000.8069 | Registry Identifier | PLATAFORMA BRASIL |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 150mg | Drug | Preemptive use of pregabalin 150 mg starting three days before surgery up to the third postoperative day |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno R Barbosa, MD | Contact | +5583991825520 | robalinho@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Luiz Antonio M Cesar, PhD | InCor Heart Institute | Study Director |
| Bruno R Barbosa, MD | InCor Heart Institute | Principal Investigator |
| André T Araújo, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital João XXIII | Recruiting | Campina Grande | Paraíba | 58400-515 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo oral tablet | Drug | Preemptive use of Placebo oral tablet starting three days before surgery up to the third postoperative day |
|
| 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 |
| UFPB Paraíba Federal University |
| Principal Investigator |
| Clínica Dom Rodrigo | Recruiting | João Pessoa | Paraíba | 58013-470 | Brazil |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |