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Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction

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ClinicalTrials.gov Identifier: NCT03876743
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Vehniah Tjong, 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.


Condition or disease Intervention/treatment
Knee Injuries ACL Injury Other: Group 1-Knee Arthroscopy Other: Group 2-Knee Arthroscopy Other: Group 1-ACL reconstruction Other: Group 2-ACL reconstruction

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: How Many Opiates Should we Prescribe for Pain in Patients Undergoing Knee Arthroscopies and ACL Reconstructions?
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: 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-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.
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.

Group 1-ACL reconstruction
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Other: Group 1-ACL reconstruction
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.
Other: Group 2-ACL reconstruction
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.




Primary Outcome Measures :
  1. Numeric Pain Rating Scale (NPRS) Pain Scores; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better [ Time Frame: 2 hours post-op ]
    2 hours post-op

  2. Opiate Count [ Time Frame: 24 hours post-op ]
    24 hours post-op

  3. Side Effects [ Time Frame: 24 hours post-op ]
    24 hours post-op

  4. Still Taking Opiates? [ Time Frame: 24 hours post-op ]
    24 hours post-op

  5. Refill Requests [ Time Frame: 24 hours post-op ]
    24 hours post-op

  6. Numeric Pain Rating Scale (NPRS) Pain Scores; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better [ Time Frame: 48 hours post-op ]
    48 hours post-op

  7. Opiate Count [ Time Frame: 48 hours post-op ]
    48 hours post-op

  8. Side Effects [ Time Frame: 48 hours post-op ]
    48 hours post-op

  9. Still Taking Opiates? [ Time Frame: 48 hours post-op ]
    48 hours post-op

  10. Refill Requests [ Time Frame: 48 hours post-op ]
    48 hours post-op

  11. Numeric Pain Rating Scale (NPRS) Pain Scores; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better [ Time Frame: 7-14 days post-op ]
    7-14 days post-op

  12. Opiate Count [ Time Frame: 7-14 days post-op ]
    7-14 days post-op

  13. Side Effects [ Time Frame: 7-14 days post-op ]
    7-14 days post-op

  14. Still Taking Opiates? [ Time Frame: 7-14 days post-op ]
    7-14 days post-op

  15. Refill Requests [ Time Frame: 7-14 days post-op ]
    7-14 days post-op



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing knee arthroscopy and patients undergoing ACL reconstruction surgery at Northwestern Memorial Hospital.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876743


Contacts
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Contact: Surabhi Bhatt, BS 312-472-6024 surabhi.bhatt@nm.org
Contact: Joshua Barrett, BS 312-472-6715 joshua.barrett@northwestern.edu

Locations
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United States, Illinois
Northwestern Medicine Department of Orthopaedic Surgery Recruiting
Chicago, Illinois, United States, 60611
Contact: Blair Faber    312-695-3248    BFaber@nm.org   
Sponsors and Collaborators
Northwestern University

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Responsible Party: Vehniah Tjong, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03876743     History of Changes
Other Study ID Numbers: STU00206152
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Knee Injuries
Anterior Cruciate Ligament Injuries
Leg Injuries
Opiate Alkaloids
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents