Clinical trial NCT03876743: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
ACL Injury
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS) Pain Score
timeFrame: 2 hours post-op
measure: Opiate Count
timeFrame: 24 hours post-op
measure: Side Effects, 24 Hours Post-op
timeFrame: 24 hours post-op
measure: Numeric Pain Rating Scale (NPRS) Pain Scores
timeFrame: 48 hours post-op
measure: Opiate Count
timeFrame: 48 hours post-op
measure: Side Effects
timeFrame: 48 hours post-op
measure: Numeric Pain Rating Scale (NPRS) Pain Scores
timeFrame: 7 days post-op
measure: Opiate Count
timeFrame: 7 days post-op
measure: Number of Participants With Side Effects
timeFrame: 7 days post-op
measure: Refill Requests
timeFrame: Within 3 months after surgery
measure: Still Taking Opiates?
timeFrame: 1 day postoperative
measure: Still Taking Opiates?
timeFrame: 2 days postoperative
measure: Still Taking Opiates?
timeFrame: 7 days postoperatively
measure: Still Taking Opiates?
timeFrame: 21 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine Department of Orthopaedic Surgery
state: Illinois
Study officials:
References:
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.