Opioid Use
Conditions
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-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).
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 effects that they may experience after surgery. Participants will be randomly assigned to receive either pregabalin in addition to usual care or usual care alone. Participants in the pregabalin group will receive two 150 mg pregabalin capsules (300 mg total dose) within 2 hours before surgery and a 75 mg pregabalin capsule twice daily after surgery until discharge from hospital to a maximum of 5 days after surgery. Participants in the usual care group will receive two placebo study capsules within 2 hours before surgery and a placebo capsule twice daily after surgery until discharged from hospital to a maximum of 5 days after surgery. OPIATE will be the largest clinical trial of pregabalin in cardiac surgery with results that are expected to set new post-operative pain management guidelines to encourage the widespread use of pregabalin in cardiac patients.
Interventions
Pregabalin 300 mg, capsule
DRUGPregabalin 75 mg
Pregabalin 75 mg twice daily, capsules
DRUGPregabalin 300 mg Placebo
Placebo, matching Pregabalin 300 mg capsule
DRUGPregabalin 75 mg Placebo
Placebo, matching Pregabalin 75 mg capsules
OTHERUsual Care
Usual Care
Sponsors
McMaster University
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Matching placebo capsules
Intervention model description
Double-blinded randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative opioid consumption | After surgery until discharge from hospital or 5 days, whichever is first. | Dose of opioids consumed (in morphine equivalents) by participants |
| Daily opioid consumption | Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first. | Dose of opioids consumed (in morphine equivalents) by participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily postoperative pain | Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first. | Acute postoperative pain assessed by the numeric rating scale (NRS; 0 to 10) |
| Average postoperative pain | Average of scores after surgery until discharge from hospital or 5 days, whichever is first. | Acute postoperative pain assessed by the numeric rating scale (NRS; 0 to 10) |
| Cumulative consumption of antiemetic medications | After surgery until discharge from hospital or 5 days, whichever is first. | Dose of gravol or ondansetron consumed by participants |
| Daily consumption of antiemetic medications | Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first. | Dose of gravol or ondansetron consumed by participants |
| Time to extubation | Within the first 5 days after surgery | Time from surgery completion until first successful extubation |
| Mobility | Within the first 5 days after surgery | Proportion of mobility goals met after surgery |
| Delirium | Starting the second day after surgery and ending after 5 days or 3 days of negative tests. | Number of participants meeting the Confusion Assessment Method (CAM) criteria |
| Major adverse cardiovascular events | Within the first 5 days after surgery | The first occurrence of death, non-fatal myocardial infarction (MI) or non-fatal stroke |
| Death | Within the first 5 days after surgery | Number of participants experiencing death from any cause |
| Myocardial infarction | Within the first 5 days after surgery | Number of participants experiencing myocardial infarction (MI) without death |
| Stroke | Within the first 5 days after surgery | Number of participants experiencing stroke without death |
Countries
Canada
Outcome results
None listed