NCT04517110

Perioperative Pregabalin for Reducing Opioid Consumption After Cardiac Surgery

Peri-Operative Pregabalin for Reducing opIoid Consumption AfTer Cardiac surgEry: A Randomized Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-09
• Primary completion: 2022-09-07
• Completion: 2022-09-07
• First posted: 2020-08-18
• Last updated: 2022-09-10

Locations

1 site across 1 country: Canada