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Completed

NCT Number: NCT03540030

Opioid-Free Shoulder Arthroplasty

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient undergoing elective primary total shoulder or reverse total shoulder arthroplasty for osteoarthritis, avascular necrosis, cuff tear arthropathy, or inflammatory arthritis etiologies
  • Age greater than or equal to 50.

Exclusion criteria

  • Revision total shoulder arthroplasty
  • Chronic opioid therapy - per investigator discretion
  • Liver or renal insufficiency - per investigator discretion
  • Arthroplasty for fracture
  • Sickle cell disease
  • Workers compensation
  • Inability to receive block
  • Intervention Arm Only: Creatinine clearance less than 30 mL/min
  • Intervention Arm Only: Allergy to non-steroidal anti-inflammatory medications (NSAIDs).

Treatment and study plan

Gabapentin

Drug

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

Celecoxib

Drug

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

Toradol

Drug

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

Acetaminophen

Drug

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

regional block

Drug

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

Propofol

Drug

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

IV Lidocaine

Drug

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

Rocuronium

Drug

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

Vecuronium

Drug

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

Sevoflurane

Drug

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

Desflurane

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Nausea

    Time frame: 2 Weeks

    rate of nausea

  3. Constipation

    Time frame: 2 Weeks

    rate of constipation

  4. Falls

    Time frame: 2 Weeks

    rate of falls

  5. 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.

  6. Pain Satisfaction

    Time frame: 2 Weeks

    Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.

  7. 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.

  8. Simple Shoulder Test

    Time frame: 2 Weeks

    Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.

  9. 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.

  10. Nausea

    Time frame: 2 Months

    rate of nausea

  11. Constipation

    Time frame: 2 Months

    rate of constipation

  12. Falls

    Time frame: 2 Months

    rate of falls

  13. Pain Satisfaction

    Time frame: 2 Months

    Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.

  14. Simple Shoulder Test

    Time frame: 2 Months

    Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.

  15. 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.

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 30, 2018
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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