Status:
TERMINATED
Perioperative Pregabalin for Reducing Opioid Consumption After Cardiac Surgery
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
McMaster University
Conditions:
Opioid Use
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
By administering oral pregabalin to patients before and after cardiac surgery for pain relief, we aim to reduce the amount of opioids they will require for pain relief and reduce opioid-related side e...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Undergoing cardiac surgery with median sternotomy
- Provide written informed consent
Exclusion
- Use of opioids or cannabis products in the past 30 days
- Daily use of pregabalin or gabapentin within 7 days of randomization
- Intravenous drug user
- Have a hypersensitivity or allergy to pregabalin
- History of previous cardiac surgery
- Undergoing minimally invasive surgery
- Emergency surgery
- Severe renal impairment (creatinine \> 250 μmol/L)
- Unable to swallow study medications
- Pregnant or breast feeding
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04517110
Start Date
April 9 2021
End Date
September 7 2022
Last Update
September 10 2022
Active Locations (1)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2