Skip to content

Multimodal Analgesia in Shoulder Arthroplasty

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

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03586934
Enrollment
0
Registered
2018-07-16
Start date
2018-06-01
Completion date
2019-06-01
Last updated
2021-09-28

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

Conditions

Shoulder Pain, Opioid Use

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.

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.

Interventions

DRUGAcetaminophen

Acetaminophen Tablet

DRUGCelecoxib 200mg

Celecoxib Tablet

Celecoxib Tablet

DRUGRopivacaine

Ropivicaine nerve block (injection)

DRUGKetorolac

ketorolac injection

Acetaminophen injection

DRUGOxycodone

oxycodone tablet

DRUGTramadol

Tramadol tablet

DRUGMorphine Injectable Solution

Morphine Patient Controlled Analgesia

DRUGhydrocodone bitartrate and acetaminophen

Norco tablet

DRUGMorphine

morphine injection

oxycodone hydrochloride tablet

DRUGMeloxicam

meloxicam tablet

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Oxycodone tabletsFrom time of discharge until the date the subject is no longer using oxycodone or up 90 days after surgery, whichever came firstNumber of tablets taken by patient after hospital discharge

Secondary

MeasureTime frameDescription
Patient Reported Outcome Measuresadministered preoperatively, 6 weeks, 3 monthsStandard shoulder surveys assessing activity and pain
Shoulder range of motion and strength testingtested as appropriate at 3 weeks, 6 weeks, and 3 monthspostoperative shoulder range of motion and strength testing
ComplicationsUp to 90 daysDeep 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
Postoperative Inpatient Opioid UtilizationFrom 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
Long-term Pain ScoresAssessed 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.
Pain ScoreFrom 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.

Other

MeasureTime frameDescription
Illinois Prescription Monitoring Program (IPMP)Up to 90 daysPatient compliance with IPMP

Countries

United States

Outcome results

None listed

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