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Opioid-Free Shoulder Arthroplasty

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ClinicalTrials.gov Identifier: NCT03540030
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

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


Condition or disease Intervention/treatment Phase
Opioid Use Shoulder Osteoarthritis Avascular Necrosis Rotator Cuff Tear Arthritis;Inflammatory Drug: Gabapentin Drug: Celecoxib Drug: toradol Drug: acetaminophen Drug: regional block Drug: propofol Drug: IV lidocaine Drug: rocuronium Drug: vecuronium Drug: sevoflurane Drug: desflurane Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Opioid-Free Shoulder Arthroplasty
Actual Study Start Date : September 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : June 2019

Arm Intervention/treatment
No Intervention: Observational
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.
Active Comparator: Non-Opioid Intervention
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.
Drug: Gabapentin
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Drug: Celecoxib
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Drug: toradol
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Drug: acetaminophen
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Drug: regional block
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Drug: propofol
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Drug: IV lidocaine
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Drug: rocuronium
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Drug: vecuronium
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Drug: sevoflurane
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Drug: desflurane
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment




Primary Outcome Measures :
  1. Post Op Pain [ Time Frame: 24 hours ]
    Pain at patient discharge or 24-hours, whichever comes first - measured on a 0-10 numeric rating scale (NRS)


Secondary Outcome Measures :
  1. Additional Post Op Pain [ Time Frame: 6hrs, 12hrs, 2 weeks, and 2 months ]
    post-operative pain: measured on a 0-10 numeric rating scale (NRS) at 6hrs, 12hrs, 2 weeks, and 2 months

  2. Nausea [ Time Frame: 1 year ]
    rate of nausea

  3. Constipation [ Time Frame: 1 year ]
    rate of constipation

  4. Continued Pain Medication [ Time Frame: 1 year ]
    continued use of pain medications

  5. Delirium post-operative [ Time Frame: 24 hours ]
    delirium score using Confusion Assessment Method 25 (CAM25). Scores Yes, if positive for delirium, or No if negative for delirium. Score is based on 4 yes/no questions, in which 1 and 2, and 3 or 4 must be "yes", for the CAM to be positive/Yes.

  6. Falls [ Time Frame: 2 month ]
    rate of falls

  7. Morphine use [ Time Frame: 1 year ]
    Morphine milli-equivalents (In-hospital operative, In-hospital post-operative, and post-discharge)

  8. Pain Satisfaction [ Time Frame: 1 year ]
    Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.

  9. ASES [ Time Frame: 1 year ]
    American Shoulder and Elbow Surgeons (ASES) Shoulder Score for pain and function. Range 0-100. Low score = worse shoulder condition. Function, disability, and pain subscores (all ranges 0-50), and are summed for total ASES score.

  10. Simple Shoulder Test [ Time Frame: 1 year ]
    Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.

  11. Veterans RAND 12 Item Health Survey (VR-12©) Physical Health subscore, and Mental Health Subscore [ Time Frame: 1 year ]
    quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540030


Locations
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United States, North Carolina
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.

Publications:

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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03540030     History of Changes
Other Study ID Numbers: Pro00021833
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by OrthoCarolina Research Institute, Inc.:
Primary Total Shoulder Arthroplasty
Reverse Total Shoulder Arthroplasty
Additional relevant MeSH terms:
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Arthritis
Necrosis
Rotator Cuff Injuries
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Acetaminophen
Celecoxib
Ketorolac Tromethamine
Ketorolac
Lidocaine
Analgesics, Opioid
Gabapentin
Propofol
Sevoflurane
Desflurane
Rocuronium
Vecuronium Bromide
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers