CLINICAL TRIAL

Pregabalin 75 mg for Opioids Use

Recruiting · 18+ · All Sexes · Hamilton, Canada

This study is evaluating whether pregabalin can reduce opioid consumption in patients undergoing on-pump cardiac surgery.

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About the trial for Opioids Use

Treatment Groups

This trial involves 2 different treatments. Pregabalin 75 Mg is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pregabalin 300 mg
DRUG
Usual Care
OTHER
Pregabalin 75 mg
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Usual Care
OTHER
Pregabalin 75 mg Placebo
DRUG
Pregabalin 300 mg Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregabalin
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
≥ 18 years of age
Undergoing cardiac surgery with median sternotomy
Provide written informed consent
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Starting the second day after surgery and ending after 5 days or 3 days of negative tests.
Screening: ~3 weeks
Treatment: Varies
Reporting: Starting the second day after surgery and ending after 5 days or 3 days of negative tests.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Starting the second day after surgery and ending after 5 days or 3 days of negative tests..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Pregabalin 75 mg will improve 2 primary outcomes and 11 secondary outcomes in patients with Opioids Use. Measurement will happen over the course of Average of scores after surgery until discharge from hospital or 5 days, whichever is first..

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)
AVERAGE OF SCORES AFTER SURGERY UNTIL DISCHARGE FROM HOSPITAL OR 5 DAYS, WHICHEVER IS FIRST.
Cumulative opioid consumption
AFTER SURGERY UNTIL DISCHARGE FROM HOSPITAL OR 5 DAYS, WHICHEVER IS FIRST.
Dose of opioids consumed (in morphine equivalents) by participants
AFTER SURGERY UNTIL DISCHARGE FROM HOSPITAL OR 5 DAYS, WHICHEVER IS FIRST.
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
AFTER SURGERY UNTIL DISCHARGE FROM HOSPITAL OR 5 DAYS, WHICHEVER IS FIRST.
Time to extubation
WITHIN THE FIRST 5 DAYS AFTER SURGERY
Time from surgery completion until first successful extubation
WITHIN THE FIRST 5 DAYS AFTER SURGERY
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
WITHIN THE FIRST 5 DAYS AFTER SURGERY
Mobility
WITHIN THE FIRST 5 DAYS AFTER SURGERY
Proportion of mobility goals met after surgery
WITHIN THE FIRST 5 DAYS AFTER SURGERY
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Who is running the study

Principal Investigator
A. L.
Andre Lamy, Cardiac Surgeon
Hamilton Health Sciences Corporation

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been other clinical trials involving pregabalin 75 mg?

There was no statistically significant difference in the analgesic use between pregabalin 75 mg and placebo. Pregabalin 75 mg can be considered a safe drug for the treatment of pain in the short term.

Anonymous Patient Answer

Who should consider clinical trials for opioids use?

In clinical trials, physicians had to consider the level of evidence, safety, and efficacy of opioids. In order to increase the enrolment rate of clinical trials, they should be tailored to the needs of an individual patient rather than generalizable for the whole study population.

Anonymous Patient Answer

What is opioids use?

In Europe, 15–20% of physicians and 10–15% of non-physicians use them, of those, 7% prescribe them, and 10% use them with other doctors. There is a need for more studies on the impact of the use of analgesics on the health status of the users, and on non-medical use of opioids. This would help the health systems to decrease their side effects and decrease the number of users.

Anonymous Patient Answer

What causes opioids use?

Most of our patients used them as a means of pain control and to counterbalance the effects of nausea or discomfort; however, there is a potential for abuse. It is important to know about opioid maintenance.

Anonymous Patient Answer

What are the signs of opioids use?

The following signs are usually the presenting symptoms of opioid use: altered consciousness, confusion, vomiting, delirium, hallucinations, coma. Patients may experience a worsening state or crisis if they have already been using opioids in an extended use. Furthermore, clinicians must look for the signs of opioid use when they see a patient. The signs may vary with the types of opioids being used. Patient history is also crucial for further examination to rule out other medical complications caused by long term use of opioids. For proper management of opioid use, patients should seek help from a medical professional. A multidisciplinary team may be needed to rule out more serious causes that look like the presentation of a patient with opioid use.

Anonymous Patient Answer

What are common treatments for opioids use?

Common treatments for those with opioid use in the United States include detoxification, naltrexone, pharmacotherapy, and substitution therapy. Those treated with naltrexone and pharmacotherapy received fewer drugs per day.

Anonymous Patient Answer

How many people get opioids use a year in the United States?

Nearly 3.3 million American adults had used an opioid-based pain relieving agent during the past month, making it the most common form of narcotic treatment in their lives. About 2.4 million Americans used opioid pain relieving agents as often or more regularly than they used aspirin, a common non-opioid pain relieving agent; approximately 0.7 million reported using these agents as often or more regularly than they used muscle relaxants; and nearly 50 million used them as often or more frequently than they used antidepressants. Opioids are the only drugs that are frequently recommended for use as initial and maintenance treatments for post-surgical pain, diabetic neuropathy (e.g.

Anonymous Patient Answer

Can opioids use be cured?

Opioids do not interfere with the healing of the incision. The use of analgesics (as compared to non-adherent analgesics) can accelerate wound healing. The use of cough medicine has no effects on postoperative pain.

Anonymous Patient Answer

Has pregabalin 75 mg proven to be more effective than a placebo?

This pilot was stopped for other reasons. After review of the data, it appears that pregabalin does not produce a dose response relationship to the analgesic effect. summary:  Results from a recent clinical trial is evaluating whether a drug called pregabalin is more effective than a placebo in treating pain from lower back/leg issues.

Anonymous Patient Answer

What are the latest developments in pregabalin 75 mg for therapeutic use?

Overall, a number of the most advanced therapies were not approved in the United States, but it was apparent that further clinical trial development was taking place and that the number of new agents being studied or in development was growing at a faster rate than was previously thought. Future development is likely to be bolstered by the advent of a gabapentinoid and a new generation of drugs designed to reduce central nervous system (CNS) toxicity.

Anonymous Patient Answer

How does pregabalin 75 mg work?

Although it has been demonstrated by the National Institute of Health that pregabalin 75 mg may have an analgesic effect, pain is likely to be less than reported when using it as preemptive treatment. Thus, if the use of pregabalin 75 mg is indicated, then dosing can be optimized in the same manner as currently used for postherpetic neuralgia.

Anonymous Patient Answer

Have there been any new discoveries for treating opioids use?

Recent results have suggested an alternative treatment that is used in countries such as Australia. This is being used by some physicians as an alternative to treat the prescription opioids that are being currently being administered to patients. This treatment allows patients to recover from their pain and return to a high quality of life.

Anonymous Patient Answer
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