← Back to Search

Liposomal bupivacaine 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
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

Study 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.Check my eligibility
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.See study design
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 below
Select...
I am having a shoulder replacement or reverse shoulder surgery.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Narcotic usage
Secondary outcome measures
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 more

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
13 Previous Clinical Trials
28,287 Total Patients Enrolled
Heinz Hoenecke, MDPrincipal InvestigatorScripps Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial permit participants aged 75 and over?

"To be eligible for this trial, applicants must fall within the age range of 50 to 85. Additionally, there are 81 trials available specifically for individuals under 18 and 467 trials structured around those 65 years of age or older."

Answered by AI

Are there any available opportunities for participants to join this experiment?

"According to the information posted on clinicaltrials.gov, this trial is presently seeking participants. The investigation was originally announced in March 2021 and was recently updated at the end of September 2021."

Answered by AI

Has the FDA sanctioned Liposomal bupivacaine?

"Liposomal bupivacaine has already been approved for medical use, so it attained a rating of 3."

Answered by AI

Who is eligible to register for this clinical experiment?

"This investigation is open to 150 participants aged 50 and 85 who have undergone total shoulder arthroplasty. Additionally, they must meet the following conditions: • Patients requiring primary shoulder arthroplasty or reverse shoulder arthroplasty."

Answered by AI

What ailments does Liposomal bupivacaine generally target?

"Liposomal bupivacaine is a useful tool for treating permphigus, as well as acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

Have prior investigations been conducted with Liposomal bupivacaine?

"At present, there are 109 active studies of Liposomal bupivacaine with 18 trials in Phase 3. Philadelphia is the epicentre for these experiments; however, there are 144 different locations running investigations into this drug."

Answered by AI

What is the aggregate number of participants in this clinical trial?

"Affirmative. Per the clinicaltrials.gov platform, this medical trial is presently seeking out participants and was initially put up on March 1st 2021 with its most recent update occurring at September 30th 2021. This study requires 150 volunteers to be recruited from one site of participation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Postoperative Pain Control in Total Shoulder Arthroplasty
Heinz Hoenecke, MD 2021. "Postoperative Pain Control in Total Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05068960.
~31 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top