Multimodal Analgesia in Shoulder Arthroplasty



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:7/19/2018
Start Date:June 1, 2018
End Date:September 1, 2020
Contact:Kassie Blanchard, MA
Email:nicholson.research@rushortho.com
Phone:312-432-2452

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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.

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.

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
We found this trial at
1
site
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-432-2452
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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from
Chicago, IL
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