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Completed

NCT Number: NCT03876743

Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction

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.

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Key information

Conditions

Knee Injuries ACL Injury Anterior Cruciate Ligament Injuries Leg Injuries Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medicine Department of Orthopaedic Surgery

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1-Knee Arthroscopy

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

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

Other

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

Group 2-ACL reconstruction

Other

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

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS) Pain Score

    Time frame: 2 hours post-op

    2 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better

  2. Opiate Count

    Time frame: 24 hours post-op

    24 hours post-op

  3. Side Effects, 24 Hours Post-op

    Time frame: 24 hours post-op

    Number of Participants with Side Effects, 24 hours post-op

  4. Numeric Pain Rating Scale (NPRS) Pain Scores

    Time frame: 48 hours post-op

    48 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better

  5. Opiate Count

    Time frame: 48 hours post-op

    48 hours post-op

  6. Side Effects

    Time frame: 48 hours post-op

    48 hours post-op

  7. Numeric Pain Rating Scale (NPRS) Pain Scores

    Time frame: 7 days post-op

    7 days post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better

  8. Opiate Count

    Time frame: 7 days post-op

    Number Pills Taken

  9. Number of Participants With Side Effects

    Time frame: 7 days post-op

    Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation

  10. Refill Requests

    Time frame: Within 3 months after surgery

    Number of participants requesting opioid refills within 3 months after surgery

  11. Still Taking Opiates?

    Time frame: 1 day postoperative

    Number of patients who took any opiates between surgery and 1 day postoperative

  12. Still Taking Opiates?

    Time frame: 2 days postoperative

    Number of patients who took any opiates between 1 day and 2 days postoperative

  13. Still Taking Opiates?

    Time frame: 7 days postoperatively

    Number of patients who took any opiates between 2 days and 7 days postoperative

  14. Still Taking Opiates?

    Time frame: 21 days postoperatively

    Number of patients who took any opiates between 7 days and 21 days postoperative

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

How Many Opiates Should we Prescribe for Pain in Patients Undergoing Knee Arthroscopies and ACL Reconstructions?

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2019
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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