Perioperative Pregabalin for Reducing Opioid Consumption After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-09

Study Completion Date

2022-09-07

Brief Summary

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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).

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Detailed Description

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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

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Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Matching placebo capsules

Study Groups

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Pregabalin + Usual Care

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.

Group Type EXPERIMENTAL

Pregabalin 300 mg

Intervention Type DRUG

Pregabalin 300 mg, capsule

Pregabalin 75 mg

Intervention Type DRUG

Pregabalin 75 mg twice daily, capsules

Usual Care

Intervention Type OTHER

Usual Care

Placebo + Usual Care

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.

Group Type PLACEBO_COMPARATOR

Pregabalin 300 mg Placebo

Intervention Type DRUG

Placebo, matching Pregabalin 300 mg capsule

Pregabalin 75 mg Placebo

Intervention Type DRUG

Placebo, matching Pregabalin 75 mg capsules

Usual Care

Intervention Type OTHER

Usual Care

Interventions

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Pregabalin 300 mg

Pregabalin 300 mg, capsule

Intervention Type DRUG

Pregabalin 75 mg

Pregabalin 75 mg twice daily, capsules

Intervention Type DRUG

Pregabalin 300 mg Placebo

Placebo, matching Pregabalin 300 mg capsule

Intervention Type DRUG

Pregabalin 75 mg Placebo

Placebo, matching Pregabalin 75 mg capsules

Intervention Type DRUG

Usual Care

Intervention Type OTHER

Other Intervention Names

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Lyrica Lyrica Placebo Capsule Placebo Capsule

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No