FindTrial
Sign In

Opioid-Free Shoulder Arthroplasty

Opioid-Free Shoulder Arthroplasty

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03540030
Enrollment
86
Registered
2018-05-30
Start date
2016-09-30
Completion date
2019-06-30
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Primary Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty

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

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.

Interventions

DRUGGabapentin

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

DRUGCelecoxib

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

DRUGtoradol

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

DRUGacetaminophen

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

DRUGregional block

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

DRUGpropofol

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

DRUGIV lidocaine

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

DRUGrocuronium

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

DRUGvecuronium

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

DRUGsevoflurane

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

DRUGdesflurane

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

Sponsors

OrthoCarolina Research Institute, Inc.
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Post Op Pain24 hoursPain 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

MeasureTime frameDescription
Nausea2 Weeksrate of nausea
Constipation2 Weeksrate of constipation
Falls2 Weeksrate of falls
Morphine UseIn-hospital StayMorphine 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.
Additional Post Op Pain6hrs, 12hrs, 2weeks, 2 monthspost-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)
ASES2 WeeksAmerican 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.
Simple Shoulder Test2 WeeksSimple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.
Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore2 Weeksquality 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.
Pain Satisfaction2 WeeksSatisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.

Countries

United States

Participant flow

Recruitment details

Patients were identified in clinic by the surgeon performing the shoulder arthroplasty. The surgeon introduced the concept of opioid-free arthroplasty with the patients, who then chose whether to follow the traditional or opioid-free pathway. The surgeon then notified the study coordinator of the patient's decision and patients were consented.

Participants by arm

ArmCount
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.
30
Non-Opioid Intervention
Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities 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). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
35
Total65

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studynever had surgery after signing consent91
Overall Studyscreen fail71
Overall StudyWithdrawal by Subject21

Baseline characteristics

CharacteristicNon-Opioid InterventionTotalObservational
Age, Continuous71.1 years72.0 years72.5 years
Race and Ethnicity Not Collected—0 Participants—
Region of Enrollment
United States
35 participants65 participants30 participants
Sex: Female, Male
Female
18 Participants38 Participants20 Participants
Sex: Female, Male
Male
17 Participants27 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 480 / 38
other
Total, other adverse events
0 / 480 / 38
serious
Total, serious adverse events
1 / 482 / 38

Outcome results

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)

Time frame: 24 hours

ArmMeasureValue (MEDIAN)
ObservationalPost Op Pain3.0 score on a scale
Non-Opioid InterventionPost Op Pain2.0 score on a scale
p-value: 0.297Wilcoxon (Mann-Whitney)
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)

Time frame: 6hrs, 12hrs, 2weeks, 2 months

ArmMeasureGroupValue (MEDIAN)
ObservationalAdditional Post Op Pain6 Hrs2 score on a scale
ObservationalAdditional Post Op Pain12 hrs4 score on a scale
ObservationalAdditional Post Op Pain2 weeks1.3 score on a scale
ObservationalAdditional Post Op Pain2 months0.7 score on a scale
Non-Opioid InterventionAdditional Post Op Pain2 months0 score on a scale
Non-Opioid InterventionAdditional Post Op Pain6 Hrs0.0 score on a scale
Non-Opioid InterventionAdditional Post Op Pain2 weeks0.82 score on a scale
Non-Opioid InterventionAdditional Post Op Pain12 hrs0 score on a scale
p-value: 0.005Wilcoxon (Mann-Whitney)
Comparison: At the 12 hour time pointp-value: 0.005Wilcoxon (Mann-Whitney)
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.

Time frame: 2 Weeks

ArmMeasureValue (MEDIAN)
ObservationalASES54.3 units on a scale
Non-Opioid InterventionASES54.2 units on a scale
p-value: 0.9669Wilcoxon (Mann-Whitney)
Secondary

Constipation

rate of constipation

Time frame: 2 Months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ObservationalConstipationYes7 Participants
ObservationalConstipationNo21 Participants
ObservationalConstipationUnknown2 Participants
Non-Opioid InterventionConstipationYes4 Participants
Non-Opioid InterventionConstipationNo27 Participants
Non-Opioid InterventionConstipationUnknown4 Participants
p-value: 0.3177Fisher Exact
Secondary

Constipation

rate of constipation

Time frame: 2 Weeks

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ObservationalConstipationYes19 Participants
ObservationalConstipationNo9 Participants
ObservationalConstipationUnknown2 Participants
Non-Opioid InterventionConstipationYes13 Participants
Non-Opioid InterventionConstipationNo22 Participants
Non-Opioid InterventionConstipationUnknown0 Participants
p-value: 0.0154Chi-squared
Secondary

Falls

rate of falls

Time frame: 2 Months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ObservationalFallsYes4 Participants
ObservationalFallsNo24 Participants
ObservationalFallsUnknown2 Participants
Non-Opioid InterventionFallsYes4 Participants
Non-Opioid InterventionFallsNo27 Participants
Non-Opioid InterventionFallsUnknown4 Participants
p-value: >0.99Fisher Exact
Secondary

Falls

rate of falls

Time frame: 2 Weeks

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ObservationalFallsYes1 Participants
ObservationalFallsNo27 Participants
ObservationalFallsUnknown2 Participants
Non-Opioid InterventionFallsYes5 Participants
Non-Opioid InterventionFallsNo30 Participants
Non-Opioid InterventionFallsUnknown0 Participants
p-value: 0.2139Fisher Exact
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.

Time frame: In-hospital Stay

ArmMeasureValue (MEDIAN)
ObservationalMorphine Use45.0 Morphine milli-equivalents
Non-Opioid InterventionMorphine Use19.0 Morphine milli-equivalents
Secondary

Nausea

rate of nausea

Time frame: 2 Months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ObservationalNauseaYes0 Participants
ObservationalNauseaNo28 Participants
ObservationalNauseaUnknown2 Participants
Non-Opioid InterventionNauseaYes1 Participants
Non-Opioid InterventionNauseaNo30 Participants
Non-Opioid InterventionNauseaUnknown0 Participants
p-value: >0.99Fisher Exact
Secondary

Nausea

rate of nausea

Time frame: 2 Weeks

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ObservationalNauseaNo23 Participants
ObservationalNauseaUnknown2 Participants
ObservationalNauseaYes5 Participants
Non-Opioid InterventionNauseaNo34 Participants
Non-Opioid InterventionNauseaUnknown0 Participants
Non-Opioid InterventionNauseaYes1 Participants
p-value: 0.0801Fisher Exact
Secondary

Pain Satisfaction

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

Time frame: 2 Weeks

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ObservationalPain SatisfactionNo1 Participants
ObservationalPain SatisfactionYes27 Participants
ObservationalPain SatisfactionUnknown2 Participants
Non-Opioid InterventionPain SatisfactionYes34 Participants
Non-Opioid InterventionPain SatisfactionNo1 Participants
Non-Opioid InterventionPain SatisfactionUnknown0 Participants
p-value: >0.99Fisher Exact
Secondary

Pain Satisfaction

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

Time frame: 2 Months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ObservationalPain SatisfactionYes23 Participants
ObservationalPain SatisfactionNo5 Participants
ObservationalPain SatisfactionUnknown2 Participants
Non-Opioid InterventionPain SatisfactionYes29 Participants
Non-Opioid InterventionPain SatisfactionNo2 Participants
Non-Opioid InterventionPain SatisfactionUnknown4 Participants
p-value: 0.2349Fisher Exact
Secondary

Simple Shoulder Test

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

Time frame: 2 Weeks

ArmMeasureValue (MEDIAN)
ObservationalSimple Shoulder Test2.0 score on a scale
Non-Opioid InterventionSimple Shoulder Test2.0 score on a scale
p-value: 0.9208Wilcoxon (Mann-Whitney)
Secondary

Simple Shoulder Test

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

Time frame: 2 Months

ArmMeasureValue (MEDIAN)
ObservationalSimple Shoulder Test6 score on a scale
Non-Opioid InterventionSimple Shoulder Test6 score on a scale
p-value: 0.7892Wilcoxon (Mann-Whitney)
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.

Time frame: 2 Months

ArmMeasureGroupValue (MEDIAN)
ObservationalVeterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health SubscorePCS38.4 score on a scale
ObservationalVeterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health SubscoreMCS58.7 score on a scale
Non-Opioid InterventionVeterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health SubscorePCS40.3 score on a scale
Non-Opioid InterventionVeterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health SubscoreMCS60.8 score on a scale
Comparison: For PCS onlyp-value: 0.2023Wilcoxon (Mann-Whitney)
Comparison: For MCS onlyp-value: 0.2486Wilcoxon (Mann-Whitney)
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.

Time frame: 2 Weeks

ArmMeasureGroupValue (MEDIAN)
ObservationalVeterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health SubscorePCS36.7 score on a scale
ObservationalVeterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health SubscoreMCS56.3 score on a scale
Non-Opioid InterventionVeterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health SubscorePCS35.0 score on a scale
Non-Opioid InterventionVeterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health SubscoreMCS59.1 score on a scale
Comparison: For PCS onlyp-value: 0.6481Wilcoxon (Mann-Whitney)
Comparison: For MCS onlyp-value: 0.3911Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026