PREemptive Analgesia With preGABAlin in HEART Surgery

NCT ID: NCT04173390

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

pregabalin

Group Type: EXPERIMENTAL

Pregabalin 150mg

Intervention Type: DRUG

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

placebo

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

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

Interventions

Pregabalin 150mg

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

Intervention Type: DRUG

Placebo oral tablet

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InCor Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Bruno Robalinho Cavalcanti Barbosa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luiz Antonio M Cesar, PhD

Role: STUDY_DIRECTOR

InCor Heart Institute

Bruno R Barbosa, MD

Role: PRINCIPAL_INVESTIGATOR

InCor Heart Institute

André T Araújo, PhD

Role: PRINCIPAL_INVESTIGATOR

UFPB Paraíba Federal University

Locations

Hospital João XXIII

Campina Grande, Paraíba, Brazil

Site Status: RECRUITING

Clínica Dom Rodrigo

João Pessoa, Paraíba, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Bruno R Barbosa, MD

Role: CONTACT

robalinho@usp.br

+5583991825520

Facility Contacts

Bruno R Barbosa, MD

Role: primary

robalinho@usp.br

+5583991825520

Andre T Araújo, PhD

Role: primary

andre_telis@globo.com

+5583993091303

Other Identifiers

17907319.5.0000.8069

Identifier Type: REGISTRY

Identifier Source: secondary_id

SDC DT 023/19/122

Identifier Type: -

Identifier Source: org_study_id