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Local Anesthetic
Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome
Phase 4
Waitlist Available
Led By Alexander Chan, MD
Research Sponsored by University of Massachusetts, Worcester
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 24-48 hours
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether low-dose naltrexone can help improve pain control and decrease opioid requirements for people undergoing Total Shoulder Replacement.
Eligible Conditions
- Postoperative Pain
- Shoulder Arthritis
- Shoulder Pain
- Infections
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Morphine Equivalent Dose of Opioids
Secondary study objectives
Cost Analysis
Hospital Length of Stay
Morphine equivalent dose of opioids
+3 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bupivacaine LiposomeExperimental Treatment1 Intervention
1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, age, or current therapy as currently determined by APS anesthesiologist).
2. Pre-operative ultrasound guided ISNB with a 20ml mixture consisting of 10ml of 0.5% bupivacaine with epinephrine 1:200,000, and 10ml of BL 1.33%
Group II: Standard therapyActive Control1 Intervention
1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, or age as currently determined by acute pain service (APS) anesthesiologist).
2. Preoperative, ultrasound guided ISNB with a bupivacaine mixture: 20ml 0.5% bupivacaine and epinephrine 1:200,000.
Find a Location
Who is running the clinical trial?
University of Massachusetts, WorcesterLead Sponsor
362 Previous Clinical Trials
992,670 Total Patients Enrolled
2 Trials studying Postoperative Pain
152 Patients Enrolled for Postoperative Pain
Alexander Chan, MDPrincipal Investigator - University of Massachusetts Chan Medical School
UMass Memorial Medical Center-Memorial Campus