A Phase 2 interventional study of Pregabalin 150mg and Placebo oral tablet in Postoperative Pain, sponsored by InCor Heart Institute. Status unknown at 2 sites in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by InCor Heart Institute · Phase 2, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 230 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →InCor Heart Institute is the lead sponsor of 26 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Pregabalin 150mg
Drug: Placebo oral tablet
Preemptive use of pregabalin 150 mg starting three days before surgery up to the third postoperative day
Preemptive use of Placebo oral tablet starting three days before surgery up to the third postoperative day
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
Analgesic opioids consumption at 72 hours post operative
Time frame: 72 hours post operative
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
Partial pressure of oxygen in millimeter of mercury (mmHg)
Time frame: 03 hours, 06 hours, 12 hours and 24 hours post operative
Partial pressure of carbon dioxide in millimeter of mercury (mmHg)
Time frame: 03 hours, 06 hours, 12 hours and 24 hours post operative
Arterial blood potential of hydrogen (pH)
Time frame: 03 hours, 06 hours, 12 hours and 24 hours post operative
Oxygen saturation in percentage (%)
Time frame: 03 hours, 06 hours, 12 hours and 24 hours post operative
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
Incidence of serious adverse events (reintubation, infection, bleeding, AKI)
Time frame: 72 hour post operative
Incidence of delirium by Confusion Assessed Method fo the Intensive Care Unity (CAM-ICU)
Time frame: 24 hour post operative
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
Plan to share: No
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This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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InCor Heart Institute