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The COVID-19 pandemic has reduced recruitment such that the study is no longer feasible
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| Name | Class |
|---|---|
| McMaster University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin + Usual Care | Experimental | 300 mg pregabalin taken orally within 2 hours before surgery and 75 mg pregabalin taken orally twice daily after surgery beginning after successful extubation (day after surgery or later) until discharge or 5 days, whichever comes first. Participants will also receive standard pain management. |
|
| Placebo + Usual Care | Placebo Comparator | Placebo taken orally within 2 hours before surgery and placebo taken orally twice daily after surgery beginning after successful extubation (day after surgery or later) until discharge or 5 days, whichever comes first. Participants will also receive standard pain management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 300 mg | Drug | Pregabalin 300 mg, capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative opioid consumption | Dose of opioids consumed (in morphine equivalents) by participants | After surgery until discharge from hospital or 5 days, whichever is first. |
| Daily opioid consumption | Dose of opioids consumed (in morphine equivalents) by participants | Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily postoperative pain | Acute postoperative pain assessed by the numeric rating scale (NRS; 0 to 10) | Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first. |
| Average postoperative pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre Lamy, MD, MHSc | Hamilton Health Sciences Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21474474 | Background | Pesonen A, Suojaranta-Ylinen R, Hammaren E, Kontinen VK, Raivio P, Tarkkila P, Rosenberg PH. Pregabalin has an opioid-sparing effect in elderly patients after cardiac surgery: a randomized placebo-controlled trial. Br J Anaesth. 2011 Jun;106(6):873-81. doi: 10.1093/bja/aer083. Epub 2011 Apr 6. | |
| 23816671 | Background |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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Double-blinded randomized controlled trial
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Matching placebo capsules
| Pregabalin 75 mg | Drug | Pregabalin 75 mg twice daily, capsules |
|
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| Pregabalin 300 mg Placebo | Drug | Placebo, matching Pregabalin 300 mg capsule |
|
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| Pregabalin 75 mg Placebo | Drug | Placebo, matching Pregabalin 75 mg capsules |
|
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| Usual Care | Other | Usual Care |
|
Acute postoperative pain assessed by the numeric rating scale (NRS; 0 to 10) |
| Average of scores after surgery until discharge from hospital or 5 days, whichever is first. |
| Cumulative consumption of antiemetic medications | Dose of gravol or ondansetron consumed by participants | After surgery until discharge from hospital or 5 days, whichever is first. |
| Daily consumption of antiemetic medications | Dose of gravol or ondansetron consumed by participants | Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first. |
| Time to extubation | Time from surgery completion until first successful extubation | Within the first 5 days after surgery |
| Mobility | Proportion of mobility goals met after surgery | Within the first 5 days after surgery |
| Delirium | Number of participants meeting the Confusion Assessment Method (CAM) criteria | Starting the second day after surgery and ending after 5 days or 3 days of negative tests. |
| Major adverse cardiovascular events | The first occurrence of death, non-fatal myocardial infarction (MI) or non-fatal stroke | Within the first 5 days after surgery |
| Death | Number of participants experiencing death from any cause | Within the first 5 days after surgery |
| Myocardial infarction | Number of participants experiencing myocardial infarction (MI) without death | Within the first 5 days after surgery |
| Stroke | Number of participants experiencing stroke without death | Within the first 5 days after surgery |
| Joshi SS, Jagadeesh AM. Efficacy of perioperative pregabalin in acute and chronic post-operative pain after off-pump coronary artery bypass surgery: a randomized, double-blind placebo controlled trial. Ann Card Anaesth. 2013 Jul-Sep;16(3):180-5. doi: 10.4103/0971-9784.114239. |
| 22234017 | Background | Sundar AS, Kodali R, Sulaiman S, Ravullapalli H, Karthekeyan R, Vakamudi M. The effects of preemptive pregabalin on attenuation of stress response to endotracheal intubation and opioid-sparing effect in patients undergoing off-pump coronary artery bypass grafting. Ann Card Anaesth. 2012 Jan-Mar;15(1):18-25. doi: 10.4103/0971-9784.91473. |
| 25830118 | Background | Ziyaeifard M, Mehrabanian MJ, Faritus SZ, Khazaei Koohpar M, Ferasatkish R, Hosseinnejad H, Mehrabanian M. Premedication with oral pregabalin for the prevention of acute postsurgical pain in coronary artery bypass surgery. Anesth Pain Med. 2015 Jan 17;5(1):e24837. doi: 10.5812/aapm.24837. eCollection 2015 Feb. |
| 28539936 | Background | Bouzia A, Tassoudis V, Karanikolas M, Vretzakis G, Petsiti A, Tsilimingas N, Arnaoutoglou E. Pregabalin Effect on Acute and Chronic Pain after Cardiac Surgery. Anesthesiol Res Pract. 2017;2017:2753962. doi: 10.1155/2017/2753962. Epub 2017 Apr 30. |
| 31149930 | Background | Anwar S, Cooper J, Rahman J, Sharma C, Langford R. Prolonged Perioperative Use of Pregabalin and Ketamine to Prevent Persistent Pain after Cardiac Surgery. Anesthesiology. 2019 Jul;131(1):119-131. doi: 10.1097/ALN.0000000000002751. |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |