PREemptive Analgesia With preGABAlin in HEART Surgery

NCT04173390 | Unknown Phase 2 DMC

• 2 other identifiers: SDC DT 023/19/12217907319.5.0000.8069
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

Study Arms (2)

pregabalin

EXPERIMENTAL

Drug: Pregabalin 150mg

placebo

PLACEBO COMPARATOR

Drug: Placebo oral tablet

Interventions

Pregabalin 150mg DRUG

Preemptive use of pregabalin 150 mg starting three days before surgery up to the third postoperative day

pregabalin

Placebo oral tablet DRUG

Preemptive use of Placebo oral tablet starting three days before surgery up to the third postoperative day

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InCor Heart Institute: lead

Study Sites (2)

Hospital João XXIII

Campina Grande, Paraíba, 58400-515, Brazil

RECRUITING

Clínica Dom Rodrigo

João Pessoa, Paraíba, 58013-470, Brazil

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Luiz Antonio M Cesar, PhD

  InCor Heart Institute

  STUDY DIRECTOR

• Bruno R Barbosa, MD

  InCor Heart Institute

  PRINCIPAL INVESTIGATOR

• André T Araújo, PhD

  UFPB Paraíba Federal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno R Barbosa, MD

CONTACT

+5583991825520; robalinho@usp.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 21, 2019
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: November 1, 2023
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)