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PREemptive Analgesia With preGABAlin in HEART Surgery

NCT04173390 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2021-02-23

No results posted yet for this study

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

Interventions

DRUG

Pregabalin 150mg

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

DRUG

Placebo oral tablet

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

Sponsors & Collaborators

  • InCor Heart Institute

    lead OTHER

Principal Investigators

  • Luiz Antonio M Cesar, PhD · InCor Heart Institute

  • Bruno R Barbosa, MD · InCor Heart Institute

  • André T Araújo, PhD · UFPB Paraíba Federal University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-12-31
Completion
2023-11-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04173390 on ClinicalTrials.gov