Perioperative Pregabalin for Reducing Opioid Consumption After Cardiac Surgery

• Status: Recruiting
• Trial end date: 2022-10-09
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborator: McMaster University
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

1. ≥ 18 years of age

2. Undergoing cardiac surgery with median sternotomy

3. Provide written informed consent

Exclusion Criteria:

1. Use of opioids or cannabis products in the past 30 days

2. Daily use of pregabalin or gabapentin within 7 days of randomization

3. Intravenous drug user

4. Have a hypersensitivity or allergy to pregabalin

5. History of previous cardiac surgery

6. Undergoing minimally invasive surgery

7. Emergency surgery

8. Severe renal impairment (creatinine > 250 μmol/L)

9. Unable to swallow study medications

10. Pregnant or breast feeding