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Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction

Primary Purpose

Knee Injuries, ACL Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group 1-Knee Arthroscopy
Group 2-Knee Arthroscopy
Group 1-ACL reconstruction
Group 2-ACL reconstruction
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Injuries

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Medicine Department of Orthopaedic Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1-Knee Arthroscopy

Group 2-Knee Arthroscopy

Group 1-ACL reconstruction

Group 2-ACL reconstruction

Arm Description

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

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.

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

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

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS) Pain Score
2 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Opiate Count
24 hours post-op
Side Effects, 24 Hours Post-op
Number of Participants with Side Effects, 24 hours post-op
Numeric Pain Rating Scale (NPRS) Pain Scores
48 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Opiate Count
48 hours post-op
Side Effects
48 hours post-op
Numeric Pain Rating Scale (NPRS) Pain Scores
7 days post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Opiate Count
Number Pills Taken
Number of Participants With Side Effects
Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation
Refill Requests
Number of participants requesting opioid refills within 3 months after surgery
Still Taking Opiates?
Number of patients who took any opiates between surgery and 1 day postoperative
Still Taking Opiates?
Number of patients who took any opiates between 1 day and 2 days postoperative
Still Taking Opiates?
Number of patients who took any opiates between 2 days and 7 days postoperative
Still Taking Opiates?
Number of patients who took any opiates between 7 days and 21 days postoperative

Secondary Outcome Measures

Full Information

First Posted
March 20, 2018
Last Updated
September 18, 2020
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03876743
Brief Title
Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction
Official Title
How Many Opiates Should we Prescribe for Pain in Patients Undergoing Knee Arthroscopies and ACL Reconstructions?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
July 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries, ACL Injury

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1-Knee Arthroscopy
Arm Type
Experimental
Arm Description
Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
Arm Title
Group 2-Knee Arthroscopy
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 1-ACL reconstruction
Arm Type
Experimental
Arm Description
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Arm Title
Group 2-ACL reconstruction
Arm Type
Experimental
Arm Description
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Intervention Type
Other
Intervention Name(s)
Group 1-Knee Arthroscopy
Intervention Description
Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
Intervention Type
Other
Intervention Name(s)
Group 2-Knee Arthroscopy
Intervention Description
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
Intervention Name(s)
Group 1-ACL reconstruction
Intervention Description
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Intervention Type
Other
Intervention Name(s)
Group 2-ACL reconstruction
Intervention Description
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS) Pain Score
Description
2 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Time Frame
2 hours post-op
Title
Opiate Count
Description
24 hours post-op
Time Frame
24 hours post-op
Title
Side Effects, 24 Hours Post-op
Description
Number of Participants with Side Effects, 24 hours post-op
Time Frame
24 hours post-op
Title
Numeric Pain Rating Scale (NPRS) Pain Scores
Description
48 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Time Frame
48 hours post-op
Title
Opiate Count
Description
48 hours post-op
Time Frame
48 hours post-op
Title
Side Effects
Description
48 hours post-op
Time Frame
48 hours post-op
Title
Numeric Pain Rating Scale (NPRS) Pain Scores
Description
7 days post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Time Frame
7 days post-op
Title
Opiate Count
Description
Number Pills Taken
Time Frame
7 days post-op
Title
Number of Participants With Side Effects
Description
Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation
Time Frame
7 days post-op
Title
Refill Requests
Description
Number of participants requesting opioid refills within 3 months after surgery
Time Frame
Within 3 months after surgery
Title
Still Taking Opiates?
Description
Number of patients who took any opiates between surgery and 1 day postoperative
Time Frame
1 day postoperative
Title
Still Taking Opiates?
Description
Number of patients who took any opiates between 1 day and 2 days postoperative
Time Frame
2 days postoperative
Title
Still Taking Opiates?
Description
Number of patients who took any opiates between 2 days and 7 days postoperative
Time Frame
7 days postoperatively
Title
Still Taking Opiates?
Description
Number of patients who took any opiates between 7 days and 21 days postoperative
Time Frame
21 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Northwestern Medicine Department of Orthopaedic Surgery
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32755488
Citation
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.
Results Reference
derived

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Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction

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