CLINICAL TRIAL

Liposomal bupivacaine for Opioid Use, Unspecified

Recruiting · 18+ · All Sexes · Madison, WI

This study is evaluating whether a mixture of liposomal and standard bupivacaine is more effective than saline for pain relief in patients undergoing cardiac surgery.

See full description

About the trial for Opioid Use, Unspecified

Eligible Conditions
Opioid Use, Unspecified · Surgery, Cardiac

Treatment Groups

This trial involves 2 different treatments. Liposomal Bupivacaine 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 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Liposomal bupivacaine
DRUG
Bupivacaine Injection
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Saline
OTHER

About The Treatment

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

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I consent to participate in this study. show original
The participant is scheduled to undergo surgery to repair or replace a heart valve via a cut made down the middle of the chest. show original
to implant a cardiac defibrillator The participant is having a cardiac procedure to implant a defibrillator. show original
Ideal body weight (IBW) is >50kg
View All
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
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 90 days post-op
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 90 days post-op
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 90 days post-op.
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 Liposomal bupivacaine will improve 1 primary outcome and 11 secondary outcomes in patients with Opioid Use, Unspecified. Measurement will happen over the course of up to 7 days.

Number of post-operative days until the Patient is Discharged
UP TO 7 DAYS
Duration of hospital stay will be measured by the number of post-operative days until the patient is discharged.
UP TO 7 DAYS
Incidence of Postoperative Delirium per the Confusion Assessment Method for the ICU (CAM-ICU)
UP TO 72 HOURS POST-OP
Postoperative delirium will be measured according to standard of care by utilizing the CAM-ICU assessment every 8-12 hours. The CAM-ICU determines either 'yes' or 'no' the participant is experiencing delirium.
UP TO 72 HOURS POST-OP
Hours of Mechanical Ventilation after ICU admission
UP TO 72 HOURS POST-OP
Duration of mechanical ventilation will be measured by hours of mechanical ventilation after admission to the ICU.
UP TO 72 HOURS POST-OP
Daily Opioid Consumption up to 72 hours Postoperatively
UP TO 72 HOURS POST-OP
Daily opioid consumption during the initial 72 hours postoperatively will be measured in morphine equivalents and compared between groups.
UP TO 72 HOURS POST-OP
Number of Hours that the Patient is in the ICU
UP TO 72 HOURS POST-OP
Duration of ICU stay will be measured by the number of hours that the patient is in the ICU until an order is placed for transfer to a lower level of care.
UP TO 72 HOURS POST-OP
Maximum Pain Scores up to 72 hours Postoperatively
UP TO 72 HOURS POST-OP
Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS) where higher score indicate worse pain, beginning at time 0 (arrival to ICU). Maximum pain scores will be compared between groups.
UP TO 72 HOURS POST-OP
See More

Patient Q & A Section

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

What causes opioid use, unspecified?

Chronic pain, psychosocial factors and psychiatric disorders are associated with opioid use, but they do not completely account for it. Some of the factors that influence the use of opioids may also contribute to opioid dependence. There are several possible reasons why opioid use leads to opioid dependence, but the exact mechanisms are not clear. These may include misuse of prescription or recreational opioids or a combination of factors and the problem of addiction. The reasons for initiating opioid use and its influence on people in their middle to late forties are unknown. The factors contributing to relapse may be different in people with and without opioid dependence.

Anonymous Patient Answer

How many people get opioid use, unspecified a year in the United States?

The number of US adults prescribed opioid analgesics in 2007 (around 1.4 million) was greater than or equal to the number prescribed in the mid-1980s (around 1 million), the mid-1990s (around 2.1 million), 2000 (around 2.3 million), and 2007 (around 2.5 million).

Anonymous Patient Answer

What are the signs of opioid use, unspecified?

Data from a recent study provides evidence of many signs of opioid use. These signs may be helpful in determining treatment options and preventing addiction.

Anonymous Patient Answer

Can opioid use, unspecified be cured?

The evidence for the use of opioids for pain is weak, because it was only based on non-randomised, rather than randomised, studies. It is therefore not known whether the use of opioids, unspecified can be cured. A randomized controlled study is needed to determine whether opioid therapy is an effective treatment for long-lasting pain or for other indications.

Anonymous Patient Answer

What is opioid use, unspecified?

Although opioid use, unspecified is a common indicator for opioid drug use, the presence of an opioid-using indication may be more important for this variable than the presence of a heroin-using indication.

Anonymous Patient Answer

What are common treatments for opioid use, unspecified?

Chronic Opioid users typically have moderate-severe pain. Almost half had a history of prior pain treatment. The most common opioids in chronic opioid users were long-acting methadone (15%), oral tramadol (12%), methadone/Tramadol (10%), and heroin (5%). Methadone and oral tramadol were equally frequently used in acute opioid users. The most useful opioids in chronic opioid users were methadone (30%), oral tramadol (28%), oral buprenorphine (19%), oral pentazocine (13%), and buprenorphine/pentazocine (13%).

Anonymous Patient Answer

Does opioid use, unspecified run in families?

Results from a recent paper of this study were most consistent with a multifactorial model; familial determinants were important, but the environmental risk factors were not. There is an urgent need for a systematic systematic family history of the disorder in those who are referred for opiate abuse treatment.

Anonymous Patient Answer

What is the average age someone gets opioid use, unspecified?

While there was a predominance of men with age < 51 years, the sample was more representative of men aged between 51-58 years, as the majority of respondents were in that age bracket, with the average for the overall sample. The majority of respondents reported use in the previous 90 days, and over half reported a history of opioid use for any reason. Many respondents reported some combination of illicit drug use and opiate use in the past 3 months. Given opioid overdose deaths from the United States has increased 10-fold since the 1990s, the number of reports that were made of opioid use, as well as those that reported illicit drug use in a 12-month period, are of concern.

Anonymous Patient Answer

Is liposomal bupivacaine typically used in combination with any other treatments?

The use of liposomal bupivacaine is not limited to use in combination with other treatments alone. It is a treatment of its own which, as of July 2016, had received U.S. Food and Drug Administration (FDA) approval.

Anonymous Patient Answer

What are the latest developments in liposomal bupivacaine for therapeutic use?

The availability of liposomal formulation has brought about the introduction of new drug delivery systems into the market. A significant increase in the therapeutic efficiency of the drug is achieved by utilising the lipophilic property of liposomes to enhance the permeability of the drug across the blood-brain barrier (BBB) (Chaudhary, CMC Pharmaceuticals, 2011; Das, Advances in Ocular Pharmacology.

Anonymous Patient Answer

What does liposomal bupivacaine usually treat?

The current literature is weak in evidence. Lidocaine/metracaine and levobupivacaine can be used in combination with morphine in perioperative epidural analgesia. However, since there is very limited observational evidence, which supports the use of liposomal bupivacaine, further randomised controlled trials are warranted.

Anonymous Patient Answer

What is the latest research for opioid use, unspecified?

Patients must be aware of the possibility for overdose as one of the adverse side effects of opioid use, and must also contemplate the possibility of a substance-induced depression if they notice significant mood changes. There is a shortage of evidence for more stringent regulations to deal with opioid safety, especially when the public is not being informed about the risk of prescription medication misuse and overdose. It is important to identify the current guidelines and laws to protect users of prescription opioids from risks, by obtaining more valid and peer-reviewed data.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Opioid Use, Unspecified by sharing your contact details with the study coordinator.