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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I weigh 60 kg or more.
Select...
I am between 18 and 90 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on post-operative day 1, day 2, day 3, day 4, day 5 and day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on post-operative day 1, day 2, day 3, day 4, day 5 and day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The difference in the proportion of patients with clinically significant tolerable pain scores
Secondary outcome measures
Adverse Block Event Survey
Opioid use in morphine milligram equivalents (MME)
The difference in Visual Analogue Scale (VAS) pain scores (0 - 10)
+3 moreTrial 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
Bupivacaine
2013
Completed Phase 4
~1530
Liposomal bupivacaine
2016
Completed Phase 4
~1970
Find a Location
Who is running the clinical trial?
NorthShore University HealthSystemOTHER
132 Previous Clinical Trials
737,538 Total Patients Enrolled
Johnny K. LeeLead Sponsor
Johnny K Lee, MDPrincipal InvestigatorNorthShore University HealthSystem
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh 60 kg or more.I need surgery urgently.I am not allergic to any local anesthetics used in the trial.I cannot use liposomal bupivacaine due to health reasons.I am younger than 18 or older than 90.I am between 18 and 90 years old.I am on dialysis for end-stage kidney disease.I weigh less than 60 kg.I am either male or female.I do not have severe liver or kidney disease.I have had a local anesthetic block before the interscalene block.I had more than one surgery during my last hospital stay.
Research Study Groups:
This trial has the following groups:- Group 1: Liposomal Bupivacaine Group
- Group 2: Plain Bupivacaine Group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants aged 45 and above eligible for this research project?
"This research endeavour is open to individuals that are older than 18 and younger than 90."
Answered by AI
Has the Liposomal Bupivacaine Group been given authorization by the FDA?
"Owing to this being a Phase 4 clinical trial, Liposomal Bupivacaine Group was rated 3 for safety. This signifies that the medication has been approved by relevant authorities."
Answered by AI
Are there any opportunities to join this medical research at the present time?
"According to information available on ClinicalTrials.gov, this medical trial is not currently open for enrolment. The initial posting was made on June 19th 2023 and the last update happened a few days later, on June 9th of the same year. Nevertheless, 501 other studies are still actively recruiting patients for their research projects."
Answered by AI
Could I be a potential candidate for this research experiment?
"To be considered for selection, applicants must have undergone total shoulder replacement surgery and fall within the 18-90 year old age range. 120 individuals will be included in this trial."
Answered by AI
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