Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction

Not Applicable

Completed

• Conditions: Knee Injuries; ACL Injury
• Interventions: Other: Group 1-Knee Arthroscopy; Other: Group 2-ACL reconstruction; Other: Group 2-Knee Arthroscopy; Other: Group 1-ACL reconstruction

• Registration Number: NCT03876743
• Lead Sponsor: Northwestern University

Brief Summary

The purpose of the study is to determine if opiates are required to achieve adequate analgesia after knee arthroscopy and ACL reconstruction in outpatient surgery.

The investigators hypothesize that patients are frequently prescribed more opiates than are needed after surgery, resulting in excess medications that are at risk for misuse, diversion and contribution to the opioid epidemic.

Detailed Description

Perioperative pain management is an important aspect of quality patient care. Opioid pain medications are increasingly being used for pain control, with the United States writing over 250 million prescriptions for painkillers per year. Increased usage has led to unintended negative consequences for individuals and society. It is estimated that 46 people die each day from an overdose of prescription painkillers, and individual use can lead to the development of tolerance and worse treatment outcomes. Further issues arise when opioids are misused, it is estimated that non-therapeutic use has increased three fold in recent years. In the United States alone in 2006 the estimated total cost of opioid prescription misuse was $53.4 billion, of which $42 billion was attributed to lost productivity, $8.2 billion to criminal justice cost and the remainder drug abuse treatment and medical complications. The federal government has recognized this epidemic and raised a call for clinicians to more responsibly prescribe opiate pain medications.

Opiate use has increased in recent years, from 2000-2010 the use of opiates in office based visits nearly doubled from 11.3% to 19.6% whereas there was no change in the prescribing of non-opioid pharmacotherapies. Further, when specifically looking at new musculoskeletal pain visits, one half resulted in pharmacologic treatment, with the prescribing of non-opioid pharmacotherapies decreasing from 38% to 29% from 2000 to 2010, respectively. The clinical use of opioids for post-operative pain control has also been linked to the opioid epidemic and risk of future abuse. Legitimate opioid use before high school graduation is independently associated with a 33% increased risk of future misuse after high school.

It has been estimated that orthopedic surgeons prescribe 7.7% of all opioids in the United States.Special attention needs to be paid to the amount of opioid pain medications orthopedic surgeons prescribe to patients after ambulatory surgery, there is considerable variability among surgeon and procedure in regards to the amount of opioids to prescribe with many patients left with excess unused medication.An analysis of 250 patients undergoing outpatient upper extremity surgery found that on average patients consumed 10 opioid pills, with 19 pills left over and a total of 4,639 pills going unused in the cohort. Leftover prescription opioids are at risk for diversion to family and friends for nonmedical use. Further studies are needed to quantify the amount of opioids to prescribe for specific orthopedic procedures to limit excess narcotic use, misuse, diversion and contribution to the opioid epidemic.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-20
• Study Start: 2018-03-26
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-15
• Primary Completion: 2020-03-23
• Study Completion: 2020-07-08
• Results First Submitted: 2020-07-29
• Results First Submitted QC: 2020-08-26
• Status Verified: 2020-09
• Results First Posted: 2020-09-16
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing knee arthroscopy with meniscus repair and/or debridement
• 18 years old or greater
• Ability to read and speak English

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Exclusion Criteria

• Revision surgery
• Oncologic surgery
• Arthroscopic knee surgery that involves procedures other than ACL or the meniscus (i.e PCL, LCL, MPFL)
• Patients currently taking narcotics, chronic pain management patients, history of substance abuse
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners
• Patients currently taking narcotics, chronic pain management patients, history of substance abuse

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1-Knee Arthroscopy	Group 1-Knee Arthroscopy	Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
Group 2-ACL reconstruction	Group 2-ACL reconstruction	Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-Knee Arthroscopy	Group 2-Knee Arthroscopy	Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed.
Group 1-ACL reconstruction	Group 1-ACL reconstruction	Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.

Primary Outcome Measures

Name	Time	Method
Opiate Count	7 days post-op	Number Pills Taken
Numeric Pain Rating Scale (NPRS) Pain Score	2 hours post-op	2 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Side Effects	48 hours post-op	48 hours post-op
Refill Requests	Within 3 months after surgery	Number of participants requesting opioid refills within 3 months after surgery
Numeric Pain Rating Scale (NPRS) Pain Scores	7 days post-op	7 days post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Side Effects, 24 Hours Post-op	24 hours post-op	Number of Participants with Side Effects, 24 hours post-op
Still Taking Opiates?	21 days postoperatively	Number of patients who took any opiates between 7 days and 21 days postoperative
Number of Participants With Side Effects	7 days post-op	Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation

Trial Locations

Locations (1)

Northwestern Medicine Department of Orthopaedic Surgery; 🇺🇸 Chicago, Illinois, United States