Phase 2
N=77
Liposome Bupivacaine Interscalene Total Shoulder
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT03587636 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Total Opioid Use — 22.5; 30.0 mg (morphine equivalent)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- liposome bupivacaine (Drug); Bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Use |
22.5; 30.0 | — |
| SECONDARY Total Maximum Pain Scores f |
4.0; 3.0 | — |
Summary
This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine alone in interscalene blocks when undergoing total shoulder arthroplasty. The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.
Eligibility Criteria
Inclusion Criteria
- All adult patients aged greater than 18 years of age that are undergoing total or reverse total shoulder arthroplasty
Exclusion Criteria
- Patients with allergy to local anesthetics, daily use of opioids for more than 3 weeks prior to surgery, patient refusal, patient with coagulopathy, non-english speaking patients, and those who do not have access to a telephone.
Data sourced from ClinicalTrials.gov (NCT03587636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.