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Local Anesthetic
Liposomal bupivacaine for Sternotomy
Phase 1
Waitlist Available
Led By Jared Staab, DO
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours post-surgery
Awards & highlights
Summary
This trial is testing a new longer-acting local anesthetic to see if it is more effective than the standard in managing pain after surgery that involves opening the sternum.
Eligible Conditions
- Sternotomy
- Pain Management
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours post-surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Morphine
Secondary study objectives
Delirium
Presence of sternal wound infection
Time to extubation in minutes will be retrieved via the electronic medical record
Trial Design
2Treatment groups
Active Control
Group I: Liposomal bupivacaineActive Control1 Intervention
Exparel (266mg) given by surgeon just prior to sternal closure
Group II: BupivacaineActive Control1 Intervention
40ml of 0.125% bupivacaine given by surgeon just prior to sternal closure
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
488 Previous Clinical Trials
172,375 Total Patients Enrolled
Jared Staab, DOPrincipal Investigator - University of Kansas Medical Center
University of Kansas Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking opioids at home for a long period of time.You have a lump or growth on the front part of your ribcage or breastbone.You had a previous surgery where your chest was opened.You have an ongoing pain condition before the study.You have an infection in your breastbone that was there before the trial started.You are allergic to any of the ingredients in liposomal bupivacaine or plain bupivacaine.
Research Study Groups:
This trial has the following groups:- Group 1: Liposomal bupivacaine
- Group 2: Bupivacaine
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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