Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction

NCT ID: NCT03876743

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-26
• Study Completion Date: 2020-07-08

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.

Conditions

Knee Injuries; ACL Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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 Type: EXPERIMENTAL

Group 1-Knee Arthroscopy

Intervention Type: OTHER

Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.

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 Type: EXPERIMENTAL

Group 2-Knee Arthroscopy

Intervention Type: OTHER

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

Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.

Group Type: EXPERIMENTAL

Group 1-ACL reconstruction

Intervention Type: OTHER

Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.

Group 2-ACL reconstruction

Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.

Group Type: EXPERIMENTAL

Group 2-ACL reconstruction

Intervention Type: OTHER

Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Group 1-ACL reconstruction

Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.

Intervention Type: OTHER

Group 2-ACL reconstruction

Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Vehniah Tjong

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern Medicine Department of Orthopaedic Surgery

Chicago, Illinois, United States

Countries

United States

References

Hartwell MJ, Selley RS, Terry MA, Tjong VK. Can We Eliminate Opioid Medications for Postoperative Pain Control? A Prospective, Surgeon-Blinded, Randomized Controlled Trial in Knee Arthroscopic Surgery. Am J Sports Med. 2020 Sep;48(11):2711-2717. doi: 10.1177/0363546520941861. Epub 2020 Aug 5.

Reference Type: DERIVED

PMID: 32755488 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

STU00206152

Identifier Type: -

Identifier Source: org_study_id