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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
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 20, 2018
Last Updated
April 28, 2022
Sponsor
University of Minnesota
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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

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Liposome Bupivacaine Interscalene Total Shoulder

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