Multimodal Analgesia in Shoulder Arthroplasty

September 27, 2021 updated by: Rush University Medical Center

Multimodal Anesthesia and Analgesia for Total Shoulder and Reverse Total Shoulder Arthroplasty: A Randomized Controlled Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

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
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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 Names:
  • Morphine
Drug: hydrocodone bitartrate and acetaminophen
Norco tablet
Other Names:
  • 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: Oxycodone
oxycodone tablet
Other Names:
  • OxyIR
Drug: Ropivacaine
Ropivicaine nerve block (injection)
Drug: Acetaminophen
Acetaminophen Tablet
Other Names:
  • Tylenol
Drug: Celecoxib 200mg
Celecoxib Tablet
Other Names:
  • Celebrex
Drug: Celecoxib 400 mg
Celecoxib Tablet
Other Names:
  • Celebrex
Drug: Ketorolac
ketorolac injection
Other Names:
  • Toradol
Drug: Acetaminophen Injectable Product
Acetaminophen injection
Other Names:
  • Tylenol
Drug: Tramadol
Tramadol tablet
Other Names:
  • Ultram
Drug: Meloxicam
meloxicam tablet
Other Names:
  • mobic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From time of discharge until the date the subject is no longer using oxycodone or up 90 days after surgery, whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcome Measures
Time Frame: administered preoperatively, 6 weeks, 3 months
Standard shoulder surveys assessing activity and pain
administered preoperatively, 6 weeks, 3 months
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
tested as appropriate at 3 weeks, 6 weeks, and 3 months
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
Up to 90 days
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.
From time of randomization until the date of hospital discharge, assessed up to 90 days after surgery.
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
From time of randomization until the date of hospital discharge, assessed up to 90 days after surgery.
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.
Assessed on a weekly basis from the time of discharge up to 90 days after surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Illinois Prescription Monitoring Program (IPMP)
Time Frame: Up to 90 days
Patient compliance with IPMP
Up to 90 days

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Gregory P Nicholson, MD, Rush University Medical Center

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

Helpful Links

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)

June 1, 2018

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

June 27, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (ACTUAL)

July 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORA 17071004

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.

No

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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