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Local Anesthetic
Liposomal Bupivicaine 1.3% for Shoulder Osteoarthritis
Phase 4
Waitlist Available
Led By Kevin Finkel, MD
Research Sponsored by Hartford Hospital
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, 24-48, 48-72, and 72-96 hours postoperation, and at day 60
Awards & highlights
Study Summary
This study is evaluating whether interscalene brachial plexus block with liposomal bupivacaine is more effective than bupivacaine with epinephrine and PF dexamethasone in reducing opioid consumption after
Eligible Conditions
- Shoulder Osteoarthritis
- Postoperative Pain
- Total Shoulder Replacement
- Pain Management
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total Opioid Consumption
Secondary outcome measures
Assessment of Patient Overall Satisfaction With Pain Control
Day of the Final Opioids Used
Duration of Sensory Nerve Block
+5 moreOther outcome measures
Total Amount of Opioid Consumed During the Indicated Time Periods
Side effects data
From 2022 Phase 4 trial • 90 Patients • NCT0388765018%
Nausea and vomiting
11%
Bruising
2%
Numbness and tingling
2%
Rash
2%
Swelling
2%
Ringing in ears
2%
Inflammation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Liposomal Bupivacaine 1.3%
Bupivacaine 0.5% With Adjuncts
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal Bupivacaine 1.3%Experimental Treatment1 Intervention
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
Group II: Bupivacaine 0.5% with AdjunctsActive Control1 Intervention
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal Bupivicaine 1.3%
2019
Completed Phase 4
~90
Find a Location
Who is running the clinical trial?
Hartford HospitalLead Sponsor
133 Previous Clinical Trials
18,842 Total Patients Enrolled
Kevin Finkel, MDPrincipal Investigator - Hartford Hospital
Institute of Living
University Of Connecticut School Of Medicine (Medical School)
Washington U/B-Jh/Slch Conc (Residency)
2 Previous Clinical Trials
164 Total Patients Enrolled
Frequently Asked Questions
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