Comparing Opioid Prescription Patterns in Total Joint Arthroplasty Patients

NCT ID: NCT03236155

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-08-26

Brief Summary

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, whose opioid prescriptions are over 7 times more likely to come from an orthopaedic surgeon than another type of physician, but orthopaedic surgeons also had the highest readmission rate 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.

The primary purpose of this randomized controlled trial is to determine whether prescribing fewer opioid pills per prescription reduces the total amount of opioids taken, even while allowing equal total opioid availability via increased frequency of prescription availability.

Detailed Description

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 age 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. Nicholas Bedard et al 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.9 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, our study will investigate regimens for effective postoperative pain control that also minimize the total amount of opioids prescribed.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1 prescription

Receives 90 pills in single prescription at discharge from hospital

Group Type: ACTIVE_COMPARATOR

opioid pain pills

Intervention Type: DRUG

patient will receive their pain pill prescription

3 prescriptions

Receives 30 pill prescription at discharge from hospital. Two refills available if requested.

Group Type: ACTIVE_COMPARATOR

opioid pain pills

Intervention Type: DRUG

patient will receive their pain pill prescription

Interventions

opioid pain pills

patient will receive their pain pill prescription

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• any patient > 18 years of age scheduled for primary total hip or knee arthroplasty who is not consuming opioids during the 4 weeks prior to surgery

Exclusion Criteria

• patients consuming opioids during the 4 weeks prior to surgery
• patients who are allergic to oxycodone or refuse to take oxycodone
• patients with a history of opioid dependence or illegal or "off-label" opioid use
• patients undergoing a revision total knee or total hip arthroplasty
• any patient less than 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Craig J Della Valle, MD

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

References

Kim N, Matzon JL, Abboudi J, Jones C, Kirkpatrick W, Leinberry CF, Liss FE, Lutsky KF, Wang ML, Maltenfort M, Ilyas AM. A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing Guidelines. J Bone Joint Surg Am. 2016 Oct 19;98(20):e89. doi: 10.2106/JBJS.15.00614.

Reference Type: BACKGROUND

PMID: 27869630 (View on PubMed)

Opioid Addiction 2016 Facts & Figures. American Society of Addiction Medicine. Retrieved from: http://www.asam.org/docs/default-source/advocacy/opioidaddiction-disease-facts-figures.pdf

Reference Type: BACKGROUND

Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.

Reference Type: BACKGROUND

PMID: 25911660 (View on PubMed)

Bedard Nicholas, Callaghan John, Pugely Andrew, Martin Christopher, Duchman Kyle, Westermann Robert, Gao Yubo. Pre-Opioid Use: Is There an Association with Outcomes Following Total Knee Arthroplasty? In: American Academy of Orthopaedic Surgeons 2016 Annual Meeting; 2016 Mar 1-5; Orlando, FL. Presentation nr P161

Reference Type: BACKGROUND

Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18.

Reference Type: BACKGROUND

PMID: 21168869 (View on PubMed)

Opioid Use, Misuse, and Abuse in Orthopaedic Practice. American Academy of Orthopaedic Surgeons. October 2015. Retrieved from: http://www.aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/adv istmt/1045%20Opioid%20Use,%20Misuse,%20and%20Abuse%20in%20Practice .pdf

Reference Type: BACKGROUND

Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National Trends in Hospitalizations for Opioid Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr. 2016 Dec 1;170(12):1195-1201. doi: 10.1001/jamapediatrics.2016.2154.

Reference Type: BACKGROUND

PMID: 27802492 (View on PubMed)

Moreno MA. Page for patients. The misuse of prescription pain medicine among children and teens. JAMA Pediatr. 2015 May;169(5):512. doi: 10.1001/jamapediatrics.2014.2128. No abstract available.

Reference Type: BACKGROUND

PMID: 25938654 (View on PubMed)

Retrieved on 12/9/16 from: https://www.whitehouse.gov/the-pressoffice/2016/12/08/continued-rise-opioid-overdose-deaths-2015-shows-urgentneed-treatment

Reference Type: BACKGROUND

Della Valle CJ, Dittle E, Moric M, Sporer SM, Buvanendran A. A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty. Clin Orthop Relat Res. 2010 Dec;468(12):3348-54. doi: 10.1007/s11999-010-1491-5. Epub 2010 Jul 29.

Reference Type: BACKGROUND

PMID: 20668969 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17030306

Identifier Type: -

Identifier Source: org_study_id