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Multimodal Analgesia in Shoulder Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03586934
Recruitment Status : Terminated (Difficult to enroll patients for the study)
First Posted : July 16, 2018
Last Update Posted : July 21, 2020
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
Opioid medications are associated with many side effects and the risk of abuse or overdose. Orthopaedic surgeons are currently investigating ways to control pain after surgery while limiting the amount of opioid medications prescribed. One way to reduce the amount of opioid medications prescribed, and potentially avoid opioid-associated adverse events, is to use multiple non-opioid medications and anesthetic drugs before surgery, during surgery, and after surgery. This study aims to evaluate a protocol with non-opioid pain medications to reduce the need for opioid medication after shoulder surgery.

Condition or disease Intervention/treatment Phase
Shoulder Pain Opioid Use Drug: Acetaminophen Drug: Celecoxib 200mg Drug: Celecoxib 400 mg Drug: Ropivacaine Drug: Ketorolac Drug: Acetaminophen Injectable Product Drug: Oxycodone Drug: Tramadol Drug: Morphine Injectable Solution Drug: hydrocodone bitartrate and acetaminophen Drug: Morphine Drug: Oxycodone Hydrochloride Drug: Meloxicam Phase 3

Detailed Description:

The United States constitutes <5% of the world's population but over 80% of the opioid supply and 99% of the hydrocodone supply. In 2014, there were 18,893 deaths from prescription drug overdose, and orthopaedic surgeons are the third highest prescribing physicians for opioids. Surgeons often prescribe opioids to minimize postoperative pain and to reduce the likelihood of readmission for pain. Available data suggests that orthopaedic surgeons are the most likely physicians to prescribe opioids to Medicare patients. Among Medicare patients, opioid prescriptions are over 7 times more likely to come from an orthopaedic surgeon than another type of physician. Yet, despite the significant amount of opioids prescribed by orthopaedic surgeons, orthopaedic surgeons often have one of the highest readmission rates for post-operative pain. Many studies have investigated the utilization of opioids after surgery to assess surgeon's tendencies to overprescribe, demographics of those likely to overuse, and adverse events of opioid abusers.

A recent paper by Kim et al. prospectively investigated opioid utilization after upper extremity surgery. This study (n=1,416) showed an opioid utilization rate of just 34%, taking an average 8.1 pills out of 24 prescribed. Patients aged 30-39, those having joint procedures, upper extremity/shoulder surgery, or self-pay/Medicaid insurance were all far more likely to overuse opioids. The study concluded that their surgeons prescribed 3 times the required opioid following surgery and gave recommendations for opioid distribution based on location, procedure type, and patient risk factors. This study's identification of over prescription is congruent with a study completed by Bates et al that showed 67% of patients had a surplus of medications, with 92% not receiving proper medication disposal instructions.

Other recent literature has attempted to risk stratify patients who are more likely to abuse prescription opioids. Morris et al. identified various risk factors including: family history of substance abuse, nicotine dependency, age <45, psychiatric disorders, and lower level of education.These risk factors are associated with aberrant behaviors (non-compliance, early refill request, "lost or stolen" medication), which should raise concerns for any provider prescribing opioids.

Studies have shown that patients who are on chronic opioid therapy before surgery have worse outcomes. A recent study compared chronic opioids users (n= 35,068) versus those who were opioid-naïve at the time of total knee arthroplasty (TKA) and found the opioid group had more opioid scripts filled per patient at discharge as well as at 3, 6, and 9 months (0.63 scripts/patient vs. 1.2 scripts/patient, p<0.05). These patients also had a higher Charlson Comorbidity Index (p<0.05) and higher rates of respiratory failure, acute kidney failure, pneumonia, all post-operative infections, and infections requiring return to the OR. The study concluded patients should have their opioid consumption controlled during the pre-operative and peri-operative period.

In addition to the complications of opioid medications experienced by orthopaedic patients, a recent nationwide retrospective analysis presents an unintended yet severe problem associated with opioid prescriptions. The incidence of pediatric hospitalizations for opioid toxicity nearly tripled from 1997 to 2012. The over-prescription of opioids creates a readily available source for accidental ingestion by younger children and for intentional opioid overdose by older pediatric/adolescent patients. In fact, a family member's leftover pills have been described as the number one source for pediatric opioid overdose. Moreover, the Center for Disease Control reported that in 2015 the U.S. saw its highest incidence of opioid-related death. Given the frequency and severity of opioid diversion and misuse, orthopaedic surgeons should consider the best methods for controlling patients postoperative pain and also avoid facilitating opiate misuse, whether by orthopaedic patients or other community members. With this goal in mind, this study will investigate regimens for effective postoperative pain control that also minimize the total amount of opioids prescribed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multimodal Anesthesia and Analgesia for Total Shoulder and Reverse Total Shoulder Arthroplasty: A Randomized Controlled Trial
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : July 17, 2020
Actual Study Completion Date : July 17, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Traditional (Standard) Protocol
Preoperative Single shot interscalene block (30 mL 0.5 ropivacaine), postoperative morphine patient controlled analgesia (1 mg/10 min/30 mg) with Hydrocodone-Acetaminophen (oral, 5/325 mg, 1 tab q4h pro re nata (PRN) for pain score of 1-3), Hydrocodone-Acetaminophen (oral, 10/325 mg, 1 tab q4h PRN for pain score of 4-6) Morphine injectable solution (2 mg IV q3h PRN for pain score 7-10), and oxycodone hydrochloride (oral, 10 mg q12h x2 doses) through postoperative day one. Discharged from hospital with hydrocodone bitartrate and acetaminophen (Norco) (5/325 mg or 10/325 mg, 1-2 oral tabs q4-6h PRN pain) script.
Drug: Ropivacaine
Ropivicaine nerve block (injection)

Drug: Morphine Injectable Solution
Morphine Patient Controlled Analgesia
Other Name: Morphine

Drug: hydrocodone bitartrate and acetaminophen
Norco tablet
Other Name: Norco

Drug: Morphine
morphine injection

Drug: Oxycodone Hydrochloride
oxycodone hydrochloride tablet
Other Names:
  • Oxycontin
  • OxyER

Experimental: Multimodal Anesthesia and Analgesia

Under age 75: Preop: acetaminophen 1000 mg oral, celecoxib 400 mg oral. Interscalene block (30 ml 0.5% ropivacaine with 1:200,000 epinephrine). Intraop: ketorolac 15 mg IV, acetaminophen injectable product. Postop: acetaminophen 500 mg oral, oxycontin 10 mg oral. Breakthrough: ketorolac 15 mg IV, oxycodone 10 mg oral. Floor: tramadol 100 mg q6h oral, acetaminophen 1 g q8h oral, celecoxib 200 mg q12h oral, ketorolac 15 mg IV q6h. Breakthrough: Pain scores 4-6: oxycodone 5 mg q4h PRN oral, pain scores 7-10: oxycodone 10 mg q4h PRN oral. Discharge: acetaminophen 1 g q8h oral, tramadol 100 mg q8h oral, celecoxib 200 mg q12h oral or meloxicam 15 mg daily oral, oxycodone 5 mg q4h PRN oral.

75 or older: Same except: Preop: celecoxib 200 mg oral. PACU meds: acetaminophen 500 mg oral. No OxyER.

Drug: Acetaminophen
Acetaminophen Tablet
Other Name: Tylenol

Drug: Celecoxib 200mg
Celecoxib Tablet
Other Name: Celebrex

Drug: Celecoxib 400 mg
Celecoxib Tablet
Other Name: Celebrex

Drug: Ropivacaine
Ropivicaine nerve block (injection)

Drug: Ketorolac
ketorolac injection
Other Name: Toradol

Drug: Acetaminophen Injectable Product
Acetaminophen injection
Other Name: Tylenol

Drug: Oxycodone
oxycodone tablet
Other Name: OxyIR

Drug: Tramadol
Tramadol tablet
Other Name: Ultram

Drug: Meloxicam
meloxicam tablet
Other Name: mobic

Primary Outcome Measures :
  1. Number of Oxycodone tablets [ Time Frame: From time of discharge until the date the subject is no longer using oxycodone or up 90 days after surgery, whichever came first ]
    Number of tablets taken by patient after hospital discharge

Secondary Outcome Measures :
  1. Patient Reported Outcome Measures [ Time Frame: administered preoperatively, 6 weeks, 3 months ]
    Standard shoulder surveys assessing activity and pain

  2. Shoulder range of motion and strength testing [ Time Frame: tested as appropriate at 3 weeks, 6 weeks, and 3 months ]
    postoperative shoulder range of motion and strength testing

  3. Complications [ Time Frame: Up to 90 days ]
    Deep vein thrombosis, pulmonary embolism, return to surgery, hospital readmission, superficial or deep infection, periprosthetic fracture, cerebrovascular accident or transient ischemic attack, dislocation, and opioid withdrawal

  4. Pain Score [ Time Frame: From time of randomization until the date of hospital discharge, assessed up to 90 days after surgery. ]
    Inpatient Pain Score- Visual Analog Scale (VAS) for pain. This is a standard pain evaluation scale rating pain 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate a better outcome.

  5. Postoperative Inpatient Opioid Utilization [ Time Frame: From time of randomization until the date of hospital discharge, assessed up to 90 days after surgery. ]
    Amount of opioid medications taken by patient in hospital

  6. Long-term Pain Scores [ Time Frame: Assessed on a weekly basis from the time of discharge up to 90 days after surgery. ]
    Pain scores of patient after hospital discharge- Visual Analog Scale (VAS) for pain. This is a standard pain evaluation scale rating pain 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate a better outcome.

Other Outcome Measures:
  1. Illinois Prescription Monitoring Program (IPMP) [ Time Frame: Up to 90 days ]
    Patient compliance with IPMP

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Greater than 18 years of Age, undergoing primary anatomic or reverse total shoulder arthroplasty

Exclusion Criteria:

  • Opioid consumption within 4 weeks prior to surgery, allergy to oxycodone or study drugs, refusal to take oxycodone or study drugs, history of opioid dependence or illegal/"off-label" opioid use, revision arthroplasty procedures

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 identifier (NCT number): NCT03586934

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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
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Principal Investigator: Gregory P Nicholson, MD Rush University Medical Center
  Study Documents (Full-Text)

Documents provided by Rush University Medical Center:
Informed Consent Form  [PDF] September 12, 2018

Additional Information:

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Responsible Party: Rush University Medical Center Identifier: NCT03586934    
Other Study ID Numbers: ORA 17071004
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
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.: No
Additional relevant MeSH terms:
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Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents