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Local Anesthetic

Liposomal Bupivacaine for Postoperative Pain in Shoulder Surgery

Phase 4
Recruiting
Led By Johnny K Lee, MD
Research Sponsored by Johnny K. Lee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight ≥ 60 kg
Subject ages 18-90 years old
Must not have
Emergency surgery
Allergy or any contraindication to local anesthetics used in trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on post-operative day 1, day 2, day 3, day 4, day 5 and day 30
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the effectiveness of two types of anesthetic for shoulder surgery.

Who is the study for?
This trial is for adults aged 18-90, weighing at least 60 kg, undergoing shoulder replacement surgery. They must understand English to give consent. It's not for those allergic to local anesthetics, pregnant women, patients with severe liver/kidney disease or on dialysis, and those having multiple surgeries in one hospital stay.
What is being tested?
The study compares pain control and opioid use after shoulder surgery between two groups: one receiving regular bupivacaine and the other getting liposomal bupivacaine mixed with a lower dose of regular bupivacaine plus saline. Participants are randomly assigned to either group without knowing which treatment they receive.
What are the potential side effects?
Possible side effects include reactions at the injection site like pain or swelling, symptoms related to nerve blocks such as weakness or numbness in the arm, and rare but serious complications like nerve damage or toxic reactions if the drug enters the bloodstream.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh 60 kg or more.
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I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need surgery urgently.
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I am not allergic to any local anesthetics used in the trial.
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I cannot use liposomal bupivacaine due to health reasons.
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I am younger than 18 or older than 90.
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I am on dialysis for end-stage kidney disease.
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I weigh less than 60 kg.
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I do not have severe liver or kidney disease.
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I have had a local anesthetic block before the interscalene block.
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I had more than one surgery during my last hospital stay.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on post-operative day 1, day 2, day 3, day 4, day 5 and day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and on post-operative day 1, day 2, day 3, day 4, day 5 and day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The difference in the proportion of patients with clinically significant tolerable pain scores
Secondary study objectives
Adverse Block Event Survey
Opioid use in morphine milligram equivalents (MME)
The difference in Visual Analogue Scale (VAS) pain scores (0 - 10)
+3 more

Awards & 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
Group I: Plain Bupivacaine GroupExperimental Treatment1 Intervention
36 mL (180 mg) 0.5% bupivacaine
Group II: Liposomal Bupivacaine GroupExperimental Treatment1 Intervention
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal bupivacaine
2016
Completed Phase 4
~1970
Bupivacaine
2013
Completed Phase 4
~1530

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemOTHER
132 Previous Clinical Trials
737,522 Total Patients Enrolled
Johnny K. LeeLead Sponsor
Johnny K Lee, MDPrincipal InvestigatorNorthShore University HealthSystem

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05900427 — Phase 4
Total Shoulder Replacement Research Study Groups: Liposomal Bupivacaine Group, Plain Bupivacaine Group
Total Shoulder Replacement Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT05900427 — Phase 4
Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05900427 — Phase 4
~53 spots leftby Dec 2025
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