Liposome Bupivacaine Interscalene Total Shoulder
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
liposome bupivacaine
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
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.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liposome bupivacaine interscalene block
bupivacaine interscalene block
Arm Description
10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance
20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.
Outcomes
Primary Outcome Measures
Total Opioid Use
total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents
Secondary Outcome Measures
Total Maximum Pain Scores f
Sum total of maximal pain scores through 72 horus after surgery. Pain scores reported on a numerical rating scale from 0-10. 10 is worse and 0 is best
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03587636
Brief Title
Liposome Bupivacaine Interscalene Total Shoulder
Official Title
Prospective Randomized Controlled Trial Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Total Shoulder Arthroplasty Surgery; a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Liposomal bupivacaine (LB) is a long acting local anesthetic. It is liposome encapsulated bupivacaine which allows for prolonged release of bupivacaine over a 72-hour period. Bupivacaine is a medium acting local anesthetic which provides between 6 and 24 hours of analgesia when used in a peripheral nerve block. Both medications are standard of care for use in interscalene blocks here at the U of MN.
LB has not been adequately studied in peripheral nerve blocks and has yet to be studied for use in interscalene blocks for Total Shoulder Arthroplasty (TSA) patients. It has been studied in Rotator Cuff Repairs (RCR) surgery and showed superior analgesia compared to bupivacaine.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposome bupivacaine interscalene block
Arm Type
Experimental
Arm Description
10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance
Arm Title
bupivacaine interscalene block
Arm Type
Active Comparator
Arm Description
20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.
Intervention Type
Drug
Intervention Name(s)
liposome bupivacaine
Other Intervention Name(s)
bupivacaine
Intervention Description
interscalene block with liposomal bupivacaine plus bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
interscalene block with bupivacaine
Primary Outcome Measure Information:
Title
Total Opioid Use
Description
total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents
Time Frame
From end of surgery through 72 hours after end of surgery
Secondary Outcome Measure Information:
Title
Total Maximum Pain Scores f
Description
Sum total of maximal pain scores through 72 horus after surgery. Pain scores reported on a numerical rating scale from 0-10. 10 is worse and 0 is best
Time Frame
time from end of surgery through 72 hours after end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Flaherty, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Liposome Bupivacaine Interscalene Total Shoulder
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