PREemptive Analgesia With preGABAlin in HEART Surgery

Postoperative Pain Clinical Trial

— PREGABA-HEART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04173390
• Other study ID #: SDC DT 023/19/122
• Secondary ID: 17907319.5.0000.
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: February 2021
• Source: InCor Heart Institute
• Contact: Bruno R Barbosa, MD
• Phone: +5583991825520
• Email: robalinho[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: November 1, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Pregabalin 150mg
Preemptive use of pregabalin 150 mg starting three days before surgery up to the third postoperative day
• Placebo oral tablet
Preemptive use of Placebo oral tablet starting three days before surgery up to the third postoperative day

Locations

Country	Name	City	State
Brazil	Hospital João XXIII	Campina Grande	Paraíba
Brazil	Clínica Dom Rodrigo	João Pessoa	Paraíba

Sponsors (1)

Lead Sponsor	Collaborator
InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Analgesic opioids consumption at 72 hours post operative		72 hours post operative
Secondary	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
Secondary	Partial pressure of oxygen in millimeter of mercury (mmHg)		03 hours, 06 hours, 12 hours and 24 hours post operative
Secondary	Partial pressure of carbon dioxide in millimeter of mercury (mmHg)		03 hours, 06 hours, 12 hours and 24 hours post operative
Secondary	Arterial blood potential of hydrogen (pH)		03 hours, 06 hours, 12 hours and 24 hours post operative
Secondary	Oxygen saturation in percentage (%)		03 hours, 06 hours, 12 hours and 24 hours post operative
Secondary	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
Secondary	Incidence of serious adverse events (reintubation, infection, bleeding, AKI)		72 hour post operative
Secondary	Incidence of delirium by Confusion Assessed Method fo the Intensive Care Unity (CAM-ICU)		24 hour post operative
Secondary	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