Liposome Bupivacaine Interscalene Total Shoulder
Prospective Randomized Controlled Trial Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Total Shoulder Arthroplasty Surgery; a Pilot Study
1 other identifier
interventional
77
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedStudy Start
First participant enrolled
September 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2021
CompletedResults Posted
Study results publicly available
May 2, 2022
CompletedMay 2, 2022
April 1, 2022
2.5 years
June 20, 2018
March 21, 2022
April 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Total Opioid Use
total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents
From end of surgery through 72 hours after end of surgery
Secondary Outcomes (1)
Total Maximum Pain Scores f
time from end of surgery through 72 hours after end of surgery
Study Arms (2)
Liposome bupivacaine interscalene block
EXPERIMENTAL10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance
bupivacaine interscalene block
ACTIVE COMPARATOR20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.
Interventions
interscalene block with liposomal bupivacaine plus bupivacaine
Eligibility Criteria
You may qualify if:
- All adult patients aged greater than 18 years of age that are undergoing total or reverse total shoulder arthroplasty
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- James Flaherty
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
James Flaherty, MD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2018
First Posted
July 16, 2018
Study Start
September 17, 2018
Primary Completion
March 15, 2021
Study Completion
March 17, 2021
Last Updated
May 2, 2022
Results First Posted
May 2, 2022
Record last verified: 2022-04