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Local Anesthetic

Bupivacaine for Postoperative Shoulder Pain

Phase 4
Recruiting
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Medically optimized patients that will undergo an elective surgery for arthroscopic shoulder surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months
Awards & highlights

Study Summary

This trial is comparing pain scores and opioid use in patients receiving interscalene peripheral blocks with plain bupivacaine versus those receiving liposomal bupivacaine.

Who is the study for?
This trial is for adults over 18, who are in good health and scheduled for elective arthroscopic shoulder surgery. They must not be pregnant, breastfeeding, or have a history of chronic opioid use. Participants should not be smokers, have an allergy to local anesthetics or opioids, extreme body weights (BMI < 18 or > 35), renal or hepatic dysfunction, respiratory issues, and must speak English.Check my eligibility
What is being tested?
The study compares pain relief and opioid consumption between two groups: one receiving plain bupivacaine and the other liposomal bupivacaine for postoperative shoulder pain. Liposomal bupivacaine may provide extended pain relief up to three days after injection. Functional status and long-term effects will also be assessed.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site such as discomfort or infection; nerve damage leading to weakness or numbness; allergic reactions; toxicity affecting the heart or nervous system; nausea; vomiting; dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am in good health and scheduled for elective shoulder surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average worst pain score with movement over 3 days
Secondary outcome measures
Adverse events
Average worst pain score with movement over 7 days
Functional Assessment with Physical Therapy
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal bupivacaineExperimental Treatment1 Intervention
Group B will receive 10 mL of 133 mg of liposomal bupivacaine mixed with 10 mL 0.5% bupivacaine.
Group II: BupivacaineActive Control1 Intervention
Patients in group A will receive a bolus injection with 20 mL of 0.5% bupivacaine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
900 Previous Clinical Trials
1,595,543 Total Patients Enrolled
2 Trials studying Shoulder Pain
154 Patients Enrolled for Shoulder Pain

Media Library

Bupivacaine Hydrochloride (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT03638960 — Phase 4
Shoulder Pain Research Study Groups: Bupivacaine, Liposomal bupivacaine
Shoulder Pain Clinical Trial 2023: Bupivacaine Hydrochloride Highlights & Side Effects. Trial Name: NCT03638960 — Phase 4
Bupivacaine Hydrochloride (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03638960 — Phase 4
Shoulder Pain Patient Testimony for trial: Trial Name: NCT03638960 — Phase 4

Frequently Asked Questions

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

Has the Food and Drug Administration accredited Bupivacaine liposome for medical use?

"Bupivacaine liposome has been approved for use, so its safety rating is 3."

Answered by AI

Could you please elaborate on the past experiments conducted using Bupivacaine liposome?

"Presently, 18 trials for Bupivacaine liposome are in their third phase of testing with a total of 109 studies on the go. Although Philadelphia has the majority of these research projects, there are other sites across 144 locations also running experiments related to this medication."

Answered by AI

Is this trial ongoing and presently open to participants?

"Affirmative, clinicaltrials.gov attests that this medical study is actively in search of participants. The trial was first listed on February 21st 2019 and its most recent update took place nearly two years later on September 27th 2021. Now, 80 people need to be enrolled from 1 site respectively."

Answered by AI

For what medical indications is Bupivacaine liposome typically employed?

"Bupivacaine liposome is commonly used to manage pemphigus and has also been known to be effective in treating acute nonspecific tenosynovitis, general anesthesia, as well as lupus erythematosus cell."

Answered by AI

What is the upper limit of individuals currently participating in this medical research?

"Affirmative, according to clinicaltrials.gov this medical trial is currently enrolling patients who meet certain criteria. The study was first made available on February 21st 2019 and the most recent modifications were done on September 27th 2021. 80 individuals are sought for participation at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
California
What site did they apply to?
University of Southern California
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
0

Why did patients apply to this trial?

pain relief and moeny from study. i am tired of living with pain and discomfort.
PatientReceived no prior treatments
i have been dealing with shoulder issues since 1994.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Phone Call
Most responsive sites:
  1. University of Southern California: < 24 hours
Recent research and studies
~13 spots leftby Mar 2025