Clinical trial NCT03540030: Opioid-Free Shoulder Arthroplasty
Official title: Opioid-Free Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Use
Shoulder Osteoarthritis
Avascular Necrosis
Rotator Cuff Tear
Arthritis;Inflammatory
Keywords: Primary Total Shoulder Arthroplasty
Reverse Total Shoulder Arthroplasty
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Post Op Pain
timeFrame: 24 hours
Secondary outcomes:
measure: Additional Post Op Pain
timeFrame: 6hrs, 12hrs, 2weeks, 2 months
measure: Nausea
timeFrame: 2 Weeks
measure: Constipation
timeFrame: 2 Weeks
measure: Falls
timeFrame: 2 Weeks
measure: Morphine Use
timeFrame: In-hospital Stay
measure: Pain Satisfaction
timeFrame: 2 Weeks
measure: ASES
timeFrame: 2 Weeks
measure: Simple Shoulder Test
timeFrame: 2 Weeks
measure: Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
timeFrame: 2 Weeks
measure: Nausea
timeFrame: 2 Months
measure: Constipation
timeFrame: 2 Months
measure: Falls
timeFrame: 2 Months
measure: Pain Satisfaction
timeFrame: 2 Months
measure: Simple Shoulder Test
timeFrame: 2 Months
measure: Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
timeFrame: 2 Months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
Study officials:
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