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Liposomal Bupivacaine vs Dexamethasone ISB
Phase 4
Waitlist Available
Led By David Kim, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24, 48, 72, 96 (if needed) hours postoperatively
Awards & highlights
Drug Has Already Been Approved
All Individual Drugs Already Approved
Approved for 60 Other Conditions
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing two different pain management techniques for shoulder surgery patients - one with just bupivacaine and one with bupivacaine and dexamethasone. Researchers will be looking at pain levels and block duration afterwards.
Eligible Conditions
- Shoulder Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24, 48, 72, 96 (if needed) hours postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24, 48, 72, 96 (if needed) hours postoperatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours
Secondary study objectives
Brief Pain Inventory Short-form
Duration of Analgesic Block
Motor Block Resolution
+7 moreSide effects data
From 2021 Phase 4 trial • 112 Patients • NCT0404744614%
Postoperative neurologic symptoms at 7 days after surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Liposomal Bupivacaine & Standard Bupivacaine
Standard Bupivacaine & Dexamethasone
Awards & 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 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal bupivacaine & standard bupivacaineExperimental Treatment1 Intervention
Group II: Standard bupivacaine & dexamethasoneActive Control1 Intervention
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?
Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
61,224 Total Patients Enrolled
2 Trials studying Shoulder Pain
210 Patients Enrolled for Shoulder Pain
David Kim, MDPrincipal InvestigatorHospital for Special Surgery, New York
1 Previous Clinical Trials
94 Total Patients Enrolled