Opioid-Free Shoulder Arthroplasty

October 9, 2020 updated by: OrthoCarolina Research Institute, Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Op Pain
Time Frame: 24 hours
Pain at patient discharge or 24-hours, whichever comes first - measured on a 0 (no pain) -10 (worst possible pain) numeric rating scale (NRS). A score of 0(no pain) is preferable to 10(worst possible pain)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Post Op Pain
Time Frame: 6hrs, 12hrs, 2weeks, 2 months
post-operative pain: measured on a 0 (no pain) -10 (worst) numeric rating scale (NRS) at 6hrs, 12hrs, 2 weeks, and 2 months. A score of 0(no pain) is preferable to 10(worst possible pain)
6hrs, 12hrs, 2weeks, 2 months
Nausea
Time Frame: 2 Weeks
rate of nausea
2 Weeks
Constipation
Time Frame: 2 Weeks
rate of constipation
2 Weeks
Falls
Time Frame: 2 Weeks
rate of falls
2 Weeks
Morphine Use
Time Frame: In-hospital Stay
Morphine milli-equivalents In-hospital post-operative. Continuous scale of MME, no defined better/worse. Measured as number and dose of medications taken. For example, if the patient received an opioid, the drug and dose was recorded and converted to MME. A time frame of when to assess opioid use in-hospital post-operative was not used but was a continuous monitor for rescue opioid from in-hospital post-operative through discharge.
In-hospital Stay
Pain Satisfaction
Time Frame: 2 Weeks
Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.
2 Weeks
ASES
Time Frame: 2 Weeks
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.
2 Weeks
Simple Shoulder Test
Time Frame: 2 Weeks
Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.
2 Weeks
Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
Time Frame: 2 Weeks
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. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health.
2 Weeks
Nausea
Time Frame: 2 Months
rate of nausea
2 Months
Constipation
Time Frame: 2 Months
rate of constipation
2 Months
Falls
Time Frame: 2 Months
rate of falls
2 Months
Pain Satisfaction
Time Frame: 2 Months
Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.
2 Months
Simple Shoulder Test
Time Frame: 2 Months
Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.
2 Months
Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
Time Frame: 2 Months
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. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health.
2 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrthoCarolina Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (ACTUAL)

May 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 9, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00021833

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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