Opioid-Free Shoulder Arthroplasty

Opioid Use Clinical Trial

Official title:

Opioid-Free Shoulder Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540030
• Other study ID #: Pro00021833
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: June 2019

Study information

• Verified date: October 2020
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis;Inflammatory
• Avascular Necrosis
• Necrosis
• Opioid Use
• Rotator Cuff Injuries
• Rotator Cuff Tear
• Shoulder Osteoarthritis

Intervention

Drug:
• Gabapentin
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
• Celecoxib
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
• toradol
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
• acetaminophen
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
• regional block
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
• propofol
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
• IV lidocaine
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
• rocuronium
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
• vecuronium
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
• sevoflurane
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
• desflurane
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Locations

Country	Name	City	State
United States	OrthoCarolina Research Institute	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Op Pain	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	Additional Post Op Pain	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
Secondary	Nausea	rate of nausea	2 Weeks
Secondary	Constipation	rate of constipation	2 Weeks
Secondary	Falls	rate of falls	2 Weeks
Secondary	Morphine Use	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
Secondary	Pain Satisfaction	Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.	2 Weeks
Secondary	ASES	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
Secondary	Simple Shoulder Test	Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.	2 Weeks
Secondary	Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore	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
Secondary	Nausea	rate of nausea	2 Months
Secondary	Constipation	rate of constipation	2 Months
Secondary	Falls	rate of falls	2 Months
Secondary	Pain Satisfaction	Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.	2 Months
Secondary	Simple Shoulder Test	Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.	2 Months
Secondary	Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore	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