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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Pregabalin 150mg; Drug: Placebo oral tablet

• Study Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bruno R Barbosa, MD; Phone Number: +5583991825520; Email: robalinho@usp.br

Study Locations

• Brazil
  • Paraíba
    • Campina Grande, Paraíba, Brazil, 58400-515
      • Recruiting
      • Hospital João XXIII
      • Contact: Bruno R Barbosa, MD; Phone Number: +5583991825520; Email: robalinho@usp.br
      • Sub-Investigator: André T Araújo, PhD
      • Principal Investigator: Bruno R Barbosa, MD
    • João Pessoa, Paraíba, Brazil, 58013-470
      • Recruiting
      • Clínica Dom Rodrigo
      • Contact: Andre T Araújo, PhD; Phone Number: +5583993091303; Email: andre_telis@globo.com
      • Principal Investigator: André T Araújo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: Placebo oral tablet; Preemptive use of Placebo oral tablet starting three days before surgery up to the third postoperative day
EXPERIMENTAL: pregabalin	Drug: Pregabalin 150mg; Preemptive use of pregabalin 150 mg starting three days before surgery up to the third postoperative day

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: InCor Heart Institute
• Investigators: Study Director: Luiz Antonio M Cesar, PhD, InCor Heart Institute; Principal Investigator: Bruno R Barbosa, MD, InCor Heart Institute; Principal Investigator: André T Araújo, PhD, UFPB Paraíba Federal University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (ACTUAL): November 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 20, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: SDC DT 023/19/122; 17907319.5.0000.8069 (REGISTRY: PLATAFORMA BRASIL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No