Opioid-Free Shoulder Arthroplasty



Status:Active, not recruiting
Conditions:Arthritis, Osteoarthritis (OA), Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:50 - Any
Updated:6/1/2018
Start Date:August 2016
End Date:June 2019

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Purpose of Study:

To identify and provide a safe, opioid-free treatment pathway for shoulder arthroplasty with
a focus on perioperative pain control and postoperative symptoms from treatment

Background and Significance:

Opioid-based analgesia has been a cornerstone of patient care in the setting of acute pain
for the last century and has undergone logarithmic increase over the past twenty years.
Unfortunately, the rise in utilization has brought with it a rise in opioid-induced side
effects. These include constipation, nausea/vomiting, hyperalgesia, delirium,
addiction/withdrawal (with 67% of those prescribed a long-term opioid program still on
opioids at an average of 4.8 years of follow-up), and in some cases even respiratory
depression/death. Patient expectations of opioid-based pain medication has driven a rapid
rise in outpatient opioid prescriptions including both short and long-acting opioids. These
prescriptions have in turn become a source of significant mortality in the United States,
with nearly 20,000 deaths due to opioid overdose in 2014 alone.

There have been momentous efforts made in identifying synergistic compounds to use for acute
pain management in the perioperative time period to begin to minimize the opioid requirement
for pain control. These studies have focused on nerve modulation with gabapentinoids,
intravenous and local administration of sodium-channel blockers such as lidocaine and
bupivacaine, and even increased interest in non-steroidal anti-inflammatories and
acetaminophen. At this time, no study has looked at the possibility of utilizing a
multi-modal acute post-surgical pain control pathway that did not include some form of opioid
medication for the general population.

Arthroplasty continues to be a dominant procedure in the orthopaedic armamentarium and
accounts for well over a million surgeries done in the United States per year. With the
ability to utilize targeted nerve blocks by anesthesia, and the increasing data showing
efficacy of multi-modal therapy for acute pain, we propose a patient care pathway that is
completely free of all opioid-based medications. From the time that patients are checked in
until the time the patient follows up in clinic, they will utilize a pathway designed to
eliminate pain and opioid-related side effects following shoulder arthroplasty. Our hope is
that a well-designed pathway for total shoulder arthroplasty can quickly be modeled for other
surgical procedures in an attempt to minimize the negative effects of opioid utilization both
acutely and on a societal level.

Inclusion Criteria:

1. Patient undergoing elective primary total shoulder or reverse total shoulder
arthroplasty for osteoarthritis, avascular necrosis, cuff tear arthropathy, or
inflammatory arthritis etiologies

2. Age greater than or equal to 50.

Exclusion Criteria:

1. Revision total shoulder arthroplasty

2. Chronic opioid therapy - per investigator discretion

3. Liver or renal insufficiency - per investigator discretion

4. Arthroplasty for fracture

5. Sickle cell disease

6. Workers compensation

7. Inability to receive block

8. Intervention Arm Only: Creatinine clearance less than 30 mL/min

9. Intervention Arm Only: Allergy to non-steroidal anti-inflammatory medications
(NSAIDs).
We found this trial at
1
site
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
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