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Perioperative Pregabalin for Reducing Opioid Consumption After Cardiac Surgery

NCT04517110 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-09-10

No results posted yet for this study

Summary

OPIATE is a double-blinded randomized controlled trial (RCT) comparing pregabalin in addition to usual care to usual care alone for reducing post-operative opioid consumption in patients undergoing on-pump cardiac surgery. Patients will be randomized in a 1:1 ratio to receive either pregabalin (300 mg pre-operatively + 75 mg post-operatively twice daily until discharge or 5 days) in addition to usual care or matching placebos in addition to usual care. The aim of the trial is to show that pregabalin is superior to usual care (i.e. a superiority trial).

Conditions

  • Opioid Use

Interventions

DRUG

Pregabalin 300 mg

Pregabalin 300 mg, capsule

DRUG

Pregabalin 75 mg

Pregabalin 75 mg twice daily, capsules

DRUG

Pregabalin 300 mg Placebo

Placebo, matching Pregabalin 300 mg capsule

DRUG

Pregabalin 75 mg Placebo

Placebo, matching Pregabalin 75 mg capsules

OTHER

Usual Care

Usual Care

Sponsors & Collaborators

Principal Investigators

  • Andre Lamy, MD, MHSc · Hamilton Health Sciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2022-09-07
Completion
2022-09-07

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT04517110 on ClinicalTrials.gov