Clinical trial NCT04173390: PREemptive Analgesia With preGABAlin in HEART Surgery
Official title: Preemptive Analgesia With Pregabalin in Heart Surgery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: InCor Heart Institute
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain perception in visual analog scale (0 means no pain and 10 is the most severe pain) at 72 hour post operative
timeFrame: 72 hours post operative
measure: Analgesic opioids consumption at 72 hours post operative
timeFrame: 72 hours post operative
Secondary outcomes:
measure: 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
timeFrame: Month 2 post operative
measure: Partial pressure of oxygen in millimeter of mercury (mmHg)
timeFrame: 03 hours, 06 hours, 12 hours and 24 hours post operative
measure: Partial pressure of carbon dioxide in millimeter of mercury (mmHg)
timeFrame: 03 hours, 06 hours, 12 hours and 24 hours post operative
measure: Arterial blood potential of hydrogen (pH)
timeFrame: 03 hours, 06 hours, 12 hours and 24 hours post operative
measure: Oxygen saturation in percentage (%)
timeFrame: 03 hours, 06 hours, 12 hours and 24 hours post operative
measure: 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)
timeFrame: 24 hour post operative
measure: Incidence of serious adverse events (reintubation, infection, bleeding, AKI)
timeFrame: 72 hour post operative
measure: Incidence of delirium by Confusion Assessed Method fo the Intensive Care Unity (CAM-ICU)
timeFrame: 24 hour post operative
measure: 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)
timeFrame: 72 hour post operative
Other outcomes:
Locations:
city: Campina Grande
country: Brazil
facility: Hospital João XXIII
state: Paraíba
city: João Pessoa
country: Brazil
facility: Clínica Dom Rodrigo
state: Paraíba
Study officials:
affiliation: InCor Heart Institute
name: Luiz Antonio M Cesar, PhD
role: STUDY_DIRECTOR
affiliation: InCor Heart Institute
name: Bruno R Barbosa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UFPB Paraíba Federal University
name: André T Araújo, PhD
role: PRINCIPAL_INVESTIGATOR
References: