AzTrials
AzTrials

Opioid UsePhase 3OPIATENCT04517110

Perioperative Pregabalin for Reducing Opioid Consumption After Cardiac Surgery

A Phase 3 study testing Pregabalin 300 mg and Pregabalin 75 mg in people with Opioid Use, run by Hamilton Health Sciences Corporation at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Use
What is being tested?
Pregabalin 300 mg and Pregabalin 75 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteCanada
Study dates
9 Apr 2021to 7 Sep 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years of age
  • Undergoing cardiac surgery with median sternotomy
  • Provide written informed consent

Who cannot join

  • 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
Show all 10Show fewer
  • Emergency surgery
  • Severe renal impairment (creatinine > 250 μmol/L)
  • Unable to swallow study medications
  • Pregnant or breast feeding

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

Other trials in Canada

About this study

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

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).

Read the 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
Being tested
Pregabalin 300 mg, Pregabalin 75 mg, Pregabalin 300 mg Placebo, Pregabalin 75 mg Placebo, Usual Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pregabalin 300 mgDrug

    Also called Lyrica

    Pregabalin 300 mg, capsule

  • Pregabalin 75 mgDrug

    Also called Lyrica

    Pregabalin 75 mg twice daily, capsules

  • Pregabalin 300 mg PlaceboDrug

    Also called Placebo Capsule

    Placebo, matching Pregabalin 300 mg capsule

  • Pregabalin 75 mg PlaceboDrug

    Also called Placebo Capsule

    Placebo, matching Pregabalin 75 mg capsules

  • Usual CareOther

    Usual Care

Study groups in NCT04517110
Study groupRoleWhat they receive
Pregabalin + Usual CareExperimental300 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.
Receives: Drug: Pregabalin 300 mg; Drug: Pregabalin 75 mg; Other: Usual Care
Placebo + Usual CarePlacebo comparatorPlacebo 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.
Receives: Drug: Pregabalin 300 mg Placebo; Drug: Pregabalin 75 mg Placebo; Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative opioid consumption

    Dose of opioids consumed (in morphine equivalents) by participants

    Measured: After surgery until discharge from hospital or 5 days, whichever is first.

  2. Daily opioid consumption

    Dose of opioids consumed (in morphine equivalents) by participants

    Measured: Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first.

Secondary outcomes (11)

  1. Daily postoperative pain

    Acute postoperative pain assessed by the numeric rating scale (NRS; 0 to 10)

    Measured: Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first.

  2. Average postoperative pain

    Acute postoperative pain assessed by the numeric rating scale (NRS; 0 to 10)

    Measured: Average of scores after surgery until discharge from hospital or 5 days, whichever is first.

  3. Cumulative consumption of antiemetic medications

    Dose of gravol or ondansetron consumed by participants

    Measured: After surgery until discharge from hospital or 5 days, whichever is first.

  4. Daily consumption of antiemetic medications

    Dose of gravol or ondansetron consumed by participants

    Measured: Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first.

  5. Time to extubation

    Time from surgery completion until first successful extubation

    Measured: Within the first 5 days after surgery

  6. Mobility

    Proportion of mobility goals met after surgery

    Measured: Within the first 5 days after surgery

  7. Delirium

    Number of participants meeting the Confusion Assessment Method (CAM) criteria

    Measured: Starting the second day after surgery and ending after 5 days or 3 days of negative tests.

  8. Major adverse cardiovascular events

    The first occurrence of death, non-fatal myocardial infarction (MI) or non-fatal stroke

    Measured: Within the first 5 days after surgery

  9. Death

    Number of participants experiencing death from any cause

    Measured: Within the first 5 days after surgery

  10. Myocardial infarction

    Number of participants experiencing myocardial infarction (MI) without death

    Measured: Within the first 5 days after surgery

  11. Stroke

    Number of participants experiencing stroke without death

    Measured: Within the first 5 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2020
  2. Study start9 Apr 2021
  3. Primary completion7 Sep 2022
  4. Study completion7 Sep 2022

Why it stopped: The COVID-19 pandemic has reduced recruitment such that the study is no longer feasible

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blinded randomized controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04517110
Sponsor's protocol ID
OPIATE-2020
Acronym
OPIATE
Status last verified
Sep 2022
First submitted
11 Aug 2020
Last updated
10 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21474474

  • 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.

    PubMed 23816671

  • 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.

    PubMed 22234017

  • 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.

    PubMed 25830118

  • 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.

    PubMed 28539936

  • 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.

    PubMed 31149930

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pregabalin 300 mg and Pregabalin 75 mg in people with Opioid Use, run by Hamilton Health Sciences Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The COVID-19 pandemic has reduced recruitment such that the study is no longer feasible). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative opioid consumption (time frame: After surgery until discharge from hospital or 5 days, whichever is first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04517110, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in