Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Injuries; ACL Injury
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine Department of Orthopaedic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 hours post-op
Opiate Count	24 hours post-op	24 hours post-op
Side Effects, 24 Hours Post-op	Number of Participants with Side Effects, 24 hours post-op	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	48 hours post-op
Opiate Count	48 hours post-op	48 hours post-op
Side Effects	48 hours post-op	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	7 days post-op
Opiate Count	Number Pills Taken	7 days post-op
Number of Participants With Side Effects	Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation	7 days post-op
Refill Requests	Number of participants requesting opioid refills within 3 months after surgery	Within 3 months after surgery
Still Taking Opiates?	Number of patients who took any opiates between surgery and 1 day postoperative	1 day postoperative
Still Taking Opiates?	Number of patients who took any opiates between 1 day and 2 days postoperative	2 days postoperative
Still Taking Opiates?	Number of patients who took any opiates between 2 days and 7 days postoperative	7 days postoperatively
Still Taking Opiates?	Number of patients who took any opiates between 7 days and 21 days postoperative	21 days postoperatively

Collaborators and Investigators

• Sponsor: Northwestern University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Actual): March 23, 2020
• Study Completion (Actual): July 8, 2020

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries; Knee Injuries
• Other Study ID Numbers: STU00206152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No