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

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Pregabalin 150mg
Placebo oral tablet
Sponsored by
InCor Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital João XXIIIRecruiting
  • Clínica Dom RodrigoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pregabalin

placebo

Arm Description

Outcomes

Primary Outcome Measures

Pain perception in visual analog scale (0 means no pain and 10 is the most severe pain) at 72 hour post operative
Analgesic opioids consumption at 72 hours post operative

Secondary Outcome Measures

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
Partial pressure of oxygen in millimeter of mercury (mmHg)
Partial pressure of carbon dioxide in millimeter of mercury (mmHg)
Arterial blood potential of hydrogen (pH)
Oxygen saturation in percentage (%)
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)
Incidence of serious adverse events (reintubation, infection, bleeding, AKI)
Incidence of delirium by Confusion Assessed Method fo the Intensive Care Unity (CAM-ICU)
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)

Full Information

First Posted
November 13, 2019
Last Updated
February 20, 2021
Sponsor
InCor Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04173390
Brief Title
PREemptive Analgesia With preGABAlin in HEART Surgery
Acronym
PREGABA-HEART
Official Title
Preemptive Analgesia With Pregabalin in Heart Surgery: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
InCor Heart Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pregabalin
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Intervention Description
Preemptive use of pregabalin 150 mg starting three days before surgery up to the third postoperative day
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Preemptive use of Placebo oral tablet starting three days before surgery up to the third postoperative day
Primary Outcome Measure Information:
Title
Pain perception in visual analog scale (0 means no pain and 10 is the most severe pain) at 72 hour post operative
Time Frame
72 hours post operative
Title
Analgesic opioids consumption at 72 hours post operative
Time Frame
72 hours post operative
Secondary Outcome Measure Information:
Title
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
Time Frame
Month 2 post operative
Title
Partial pressure of oxygen in millimeter of mercury (mmHg)
Time Frame
03 hours, 06 hours, 12 hours and 24 hours post operative
Title
Partial pressure of carbon dioxide in millimeter of mercury (mmHg)
Time Frame
03 hours, 06 hours, 12 hours and 24 hours post operative
Title
Arterial blood potential of hydrogen (pH)
Time Frame
03 hours, 06 hours, 12 hours and 24 hours post operative
Title
Oxygen saturation in percentage (%)
Time Frame
03 hours, 06 hours, 12 hours and 24 hours post operative
Title
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)
Time Frame
24 hour post operative
Title
Incidence of serious adverse events (reintubation, infection, bleeding, AKI)
Time Frame
72 hour post operative
Title
Incidence of delirium by Confusion Assessed Method fo the Intensive Care Unity (CAM-ICU)
Time Frame
24 hour post operative
Title
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)
Time Frame
72 hour post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno R Barbosa, MD
Phone
+5583991825520
Email
robalinho@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz Antonio M Cesar, PhD
Organizational Affiliation
InCor Heart Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bruno R Barbosa, MD
Organizational Affiliation
InCor Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
André T Araújo, PhD
Organizational Affiliation
UFPB Paraíba Federal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital João XXIII
City
Campina Grande
State/Province
Paraíba
ZIP/Postal Code
58400-515
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno R Barbosa, MD
Phone
+5583991825520
Email
robalinho@usp.br
First Name & Middle Initial & Last Name & Degree
André T Araújo, PhD
First Name & Middle Initial & Last Name & Degree
Bruno R Barbosa, MD
Facility Name
Clínica Dom Rodrigo
City
João Pessoa
State/Province
Paraíba
ZIP/Postal Code
58013-470
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre T Araújo, PhD
Phone
+5583993091303
Email
andre_telis@globo.com
First Name & Middle Initial & Last Name & Degree
André T Araújo, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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PREemptive Analgesia With preGABAlin in HEART Surgery

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