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Pain Control for Total Shoulder Replacement
Phase 4
Recruiting
Led By Heinz Hoenecke, MD
Research Sponsored by Scripps Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty
Be older than 18 years old
Must not have
Patients under the age of 50 years
Patients undergoing a revision shoulder procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
Awards & highlights
Drug Has Already Been Approved
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether adding a certain medication to a common pain-relieving treatment for shoulder surgery results in less pain, fewer narcotics needed, and higher satisfaction for patients.
Who is the study for?
This trial is for patients between the ages of 50 and 85 who are having their first shoulder replacement surgery. It's not suitable for those with oxycodone intolerance, conditions that make interscalene block risky, active narcotic use in the past 3 months, allergy to amide anesthetics, inability to take Celebrex, or cognitive issues affecting participation.
What is being tested?
The study is testing if adding liposomal bupivacaine to a standard pain blocker (interscalene block) improves pain control after shoulder replacement surgery. Patients will be randomly assigned to receive either the new combination or just the standard treatment without knowing which one they get.
What are the potential side effects?
Possible side effects may include reactions at the injection site like pain or swelling, nerve damage symptoms such as weakness or numbness around the shoulder area, and typical anesthesia-related risks like nausea or dizziness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a shoulder replacement or reverse shoulder surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 50 years old.
Select...
I am having a second surgery on my shoulder.
Select...
I have a neurological condition affecting my movement or senses.
Select...
I am over 85 years old.
Select...
I cannot take Celebrex.
Select...
I have a health condition that makes nerve block anesthesia unsafe for me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Narcotic usage
Secondary study objectives
American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively
Non narcotic pain medication usage
Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively
+2 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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.
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: Study groupExperimental Treatment2 Interventions
The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine \[133mg\].
Group II: Control groupActive Control1 Intervention
The control group will receive an interscalene block consisting of 20 mL of 0.5%bupivacaine alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Bupivacaine
FDA approved
Find a Location
Who is running the clinical trial?
Scripps ClinicLead Sponsor
14 Previous Clinical Trials
28,363 Total Patients Enrolled
Heinz Hoenecke, MDPrincipal InvestigatorScripps Health