Opioid-Free Shoulder Arthroplasty

OrthoCarolina Research Institute, Inc.

Status and phase: Completed; Phase 4

Conditions: Rotator Cuff Tear; Shoulder Osteoarthritis; Arthritis;Inflammatory; Opioid Use; Avascular Necrosis

Treatments: Drug: Celecoxib; Drug: regional block; Drug: rocuronium; Drug: IV lidocaine; Drug: Gabapentin; Drug: desflurane; Drug: acetaminophen; Drug: propofol; Drug: vecuronium; Drug: toradol; Drug: sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT03540030

Pro00021833

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Observational

No Intervention group

Description:

The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.

Non-Opioid Intervention

Active Comparator group

Description:

Oral dose of both gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without the aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but should include one dose of IV acetaminophen during the procedure. Anesthetic modalities will include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). As needed medications will include both oral and IV acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.

Treatment:

Drug: vecuronium

Drug: desflurane

Drug: toradol

Drug: regional block

Drug: rocuronium

Drug: IV lidocaine

Drug: Gabapentin

Drug: acetaminophen

Drug: sevoflurane

Drug: propofol

Drug: Celecoxib