Liposome Bupivacaine Interscalene Total Shoulder



Status:Recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:7/21/2018
Start Date:July 17, 2018
End Date:December 2018
Contact:James Flaherty, MD
Email:jflahert@umn.edu
Phone:612-624-9990

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Prospective Randomized Controlled Trial Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Total Shoulder Arthroplasty Surgery; a Pilot Study

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.

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.

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.
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-625-7116
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
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