Comparing Opioid Prescription Patterns in Total Joint Arthroplasty Patients

NCT03236155 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17030306
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Opioids

Outcome Measures

Primary Outcomes (1)

• Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient

  Self-reported by patient, we are asking for the number of Oxycodone taken by patients (5mg doses). This will be verified with patient bringing their pill bottle in and counted by a study investigator.

  30 days

Secondary Outcomes (8)

• Postoperative Patient Reported Outcomes of Opioid naïve Patients Undergoing THA or TKA Between August 2017 and April 2018

  90 days post operative (higher values represent better functioning total hip or total knee replacements).

• Complications

  90 days from time of surgery

• Compliance

  90 days

• Preoperative Patient Reported Outcomes

  10 days prior to surgery (higher values represent better functioning total hip or total knee replacements).

• Postoperative Outpatient Pain Scores

  Days 1-3, 1 week, 2 weeks, and 3-4 weeks post discharge from surgery

Study Arms (2)

1 prescription

ACTIVE COMPARATOR

Receives 90 pills in single prescription at discharge from hospital

Drug: opioid pain pills

3 prescriptions

ACTIVE COMPARATOR

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

Drug: opioid pain pills

Interventions

opioid pain pills DRUG

patient will receive their pain pill prescription

1 prescription; 3 prescriptions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (10)

• 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.

  PMID: 27869630 BACKGROUND

• 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

  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.

  PMID: 25911660 BACKGROUND

• 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

  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.

  PMID: 21168869 BACKGROUND

• 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

  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.

  PMID: 27802492 BACKGROUND

• 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.

  PMID: 25938654 BACKGROUND

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

  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.

  PMID: 20668969 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Anne DeBenedetti, CRC
• Organization: Rush University Medical Center

anne.debenedetti@rushortho.com

3124322468

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 1, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: August 26, 2018
• Last Updated: July 20, 2023
• Results First Posted: July 20, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)