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Local Anesthetic
Liposomal Bupivacaine for Postoperative Pain in Rotator Cuff Tears
Phase 3
Waitlist Available
Led By Nabil M Elkassabany, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mental competency
Age greater than 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
Study Summary
This trial is testing whether using liposomal bupivacaine for an interscalene nerve block (which numbs the shoulder and arm) will improve pain control and the patient's experience 48 hours after surgery, when compared to using regular bupivacaine with dexamethasone.
Who is the study for?
This trial is for adults over 18 with good mental capacity and physical health (ASA I-III), who can consent to participate. It's not for those with severe lung disease, chronic pain requiring daily opioids, allergies to study drugs, or conditions preventing nerve blocks like bleeding disorders.Check my eligibility
What is being tested?
The study compares two types of anesthesia in shoulder surgery: Group 1 gets a mix of Liposomal Bupivacaine and regular Bupivacaine; Group 2 gets regular Bupivacaine with Dexamethasone. Patients are randomly assigned to groups and receive standardized care before, during, after surgery.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, nausea from anesthesia or pain meds used post-surgery. There may also be risks associated with nerve blocks such as numbness or weakness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mentally capable of making my own decisions.
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I am older than 18 years.
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My overall health is good to moderately impaired.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Opioid Use
PACU LOS
PACU Medications
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: GROUP 2 Bupivacaine with dexamethasoneExperimental Treatment1 Intervention
Will receive 20 ml of Bupivacaine HCl 0.5% with 4 mg of preservative-free dexamethasone.
Group II: GROUP 1 Liposomal BupivacaineExperimental Treatment1 Intervention
Will receive a 20 ml mixture of 10 ml of Liposomal Bupivacaine 1.3% and 10 ml of Bupivacaine HCl 0.5%.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal bupivacaine
2016
Completed Phase 4
~1970
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,283 Total Patients Enrolled
Nabil M Elkassabany, MDPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
221 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mentally capable of making my own decisions.I have chosen not to participate in certain treatments.I have severe lung disease such as COPD.I am older than 18 years.I cannot have a nerve block because of blood thinners or infection.I have a nerve injury.You are allergic to any of the study medications or any of the medications in the pain relief treatment plan.My overall health is good to moderately impaired.I have been taking opioids daily for pain for more than three months before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: GROUP 2 Bupivacaine with dexamethasone
- Group 2: GROUP 1 Liposomal Bupivacaine
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the standard reason this therapy is prescribed?
"This type of treatment is most commonly used to deal with ophthalmia and sympathetic. However, it can also help patients that have branch retinal vein occlusion, macular edema, or communicable diseases."
Answered by AI
Is this medication legally allowed to be prescribed in the United States?
"Given that this is a Phase 3 trial - meaning there is both some evidence of efficacy and multiple rounds of data affirming safety - our team has given this treatment a score of 3 for safety."
Answered by AI
Are recruitment and enrollment still underway for this clinical trial?
"That is correct. The clinicaltrials.gov website says that the study is still looking for enrollees and provides the most recent update date of 10/29/2021. This research was originally posted on 2/21/2019 and is taking place at 1 location with a goal of 200 participants."
Answered by AI
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