ACL Injury, Knee Injuries
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) Pain Score | 2 hours post-op | 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 | 24 hours post-op |
| Side Effects, 24 Hours Post-op | 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 | 48 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better |
| Side Effects | 48 hours post-op | 48 hours post-op |
| Number of Participants With Side Effects | 7 days post-op | Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation |
| Refill Requests | Within 3 months after surgery | Number of participants requesting opioid refills within 3 months after surgery |
| Still Taking Opiates? | 1 day postoperative | Number of patients who took any opiates between surgery and 1 day postoperative |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (Filled)-Knee Arthroscopy Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
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. | 54 |
| Group 2 (as Needed)-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 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. | 51 |
| Group 1 (60)-ACL Reconstruction Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. | 46 |
| Group 2 (30)-ACL Reconstruction Will be prescribed 30 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. | 50 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 | 4 | 7 |
Baseline characteristics
| Characteristic | Group 1 (Filled)-Knee Arthroscopy | Total | Group 2 (as Needed)-Knee Arthroscopy | Group 2 (30)-ACL Reconstruction | Group 1 (60)-ACL Reconstruction |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 200 Participants | 51 Participants | 50 Participants | 46 Participants |
| Age, Continuous | 43.8 Years STANDARD_DEVIATION 12.5 | 38.1 Years STANDARD_DEVIATION 12.6 | 43.2 Years STANDARD_DEVIATION 13.2 | 31.3 Years STANDARD_DEVIATION 10 | 33.2 Years STANDARD_DEVIATION 8.9 |
| Are you actively participating in sporting activities? No | 40 Participants | 113 Participants | 35 Participants | 18 Participants | 20 Participants |
| Are you actively participating in sporting activities? Yes | 14 Participants | 88 Participants | 16 Participants | 32 Participants | 26 Participants |
| Are you an active smoker? No | 49 Participants | 184 Participants | 44 Participants | 46 Participants | 45 Participants |
| Are you an active smoker? Yes | 5 Participants | 17 Participants | 7 Participants | 4 Participants | 1 Participants |
| Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/Oxycodone) ? No | 54 Participants | 201 Participants | 51 Participants | 50 Participants | 46 Participants |
| Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/Oxycodone) ? Yes | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| At what level (i.e. professional, collegiate, recreational)? Collegiate | 2 Participants | 10 Participants | 3 Participants | 2 Participants | 3 Participants |
| At what level (i.e. professional, collegiate, recreational)? N/A | 40 Participants | 110 Participants | 35 Participants | 17 Participants | 18 Participants |
| At what level (i.e. professional, collegiate, recreational)? Professional | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| At what level (i.e. professional, collegiate, recreational)? Recreational | 12 Participants | 79 Participants | 13 Participants | 29 Participants | 25 Participants |
| Body Mass Index | 29.2 kg/m^2 STANDARD_DEVIATION 7.6 | 28.4 kg/m^2 STANDARD_DEVIATION 6.7 | 29.8 kg/m^2 STANDARD_DEVIATION 7.9 | 28.1 kg/m^2 STANDARD_DEVIATION 6 | 26.4 kg/m^2 STANDARD_DEVIATION 4.1 |
| Do you have a family history of illicit substance abuse? No | 50 Participants | 180 Participants | 47 Participants | 44 Participants | 39 Participants |
| Do you have a family history of illicit substance abuse? Yes | 4 Participants | 21 Participants | 4 Participants | 6 Participants | 7 Participants |
| Do you have a personal history of illicit substance abuse? No | 54 Participants | 201 Participants | 51 Participants | 50 Participants | 46 Participants |
| Do you have a personal history of illicit substance abuse? Yes | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| If no, have you ever consistently smoked cigarettes (daily for >1 month)? No | 47 Participants | 169 Participants | 37 Participants | 44 Participants | 41 Participants |
| If no, have you ever consistently smoked cigarettes (daily for >1 month)? Yes | 2 Participants | 15 Participants | 7 Participants | 2 Participants | 4 Participants |
| Is this injury part of a workers compensation claim? No | 54 Participants | 198 Participants | 50 Participants | 49 Participants | 45 Participants |
| Is this injury part of a workers compensation claim? Yes | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — | — |
| Sex: Female, Male Female | 31 Participants | 96 Participants | 20 Participants | 23 Participants | 22 Participants |
| Sex: Female, Male Male | 23 Participants | 105 Participants | 31 Participants | 27 Participants | 24 Participants |
| What is the highest level of education you have attained? Completed High School | 12 Participants | 36 Participants | 7 Participants | 11 Participants | 6 Participants |
| What is the highest level of education you have attained? Graduate | 17 Participants | 61 Participants | 18 Participants | 10 Participants | 16 Participants |
| What is the highest level of education you have attained? Undergraduate | 25 Participants | 104 Participants | 26 Participants | 29 Participants | 24 Participants |
| What is your average yearly household income? $100,000 -$149,999 | 4 Participants | 31 Participants | 11 Participants | 8 Participants | 8 Participants |
| What is your average yearly household income? $150,000 - $199,999 | 9 Participants | 15 Participants | 1 Participants | 2 Participants | 3 Participants |
| What is your average yearly household income? $200,000 or more | 10 Participants | 32 Participants | 10 Participants | 4 Participants | 8 Participants |
| What is your average yearly household income? $20,000 -$34,999 | 3 Participants | 7 Participants | 1 Participants | 2 Participants | 1 Participants |
| What is your average yearly household income? $35,000 -$49,999 | 10 Participants | 26 Participants | 4 Participants | 8 Participants | 4 Participants |
| What is your average yearly household income? $50,000 -$74,999 | 8 Participants | 42 Participants | 10 Participants | 13 Participants | 11 Participants |
| What is your average yearly household income? $75,000 - $99,999 | 8 Participants | 32 Participants | 8 Participants | 9 Participants | 7 Participants |
| What is your average yearly household income? Less than $20,000 | 2 Participants | 16 Participants | 6 Participants | 4 Participants | 4 Participants |
| What is your employment status? Disabled | 1 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants |
| What is your employment status? Employed | 48 Participants | 163 Participants | 40 Participants | 36 Participants | 39 Participants |
| What is your employment status? Retired | 3 Participants | 8 Participants | 3 Participants | 1 Participants | 1 Participants |
| What is your employment status? Unemployed | 2 Participants | 26 Participants | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 47 | 0 / 43 | 0 / 42 |
| other Total, other adverse events | 0 / 48 | 0 / 47 | 0 / 43 | 0 / 42 |
| serious Total, serious adverse events | 0 / 48 | 0 / 47 | 0 / 43 | 0 / 42 |
Outcome results
Number of Participants With Side Effects
Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation
Time frame: 7 days post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1-Knee Arthroscopy | Number of Participants With Side Effects | 7 Participants |
| Group 2-Knee Arthroscopy | Number of Participants With Side Effects | 5 Participants |
| Group 1-ACL Reconstruction | Number of Participants With Side Effects | 24 Participants |
| Group 2-ACL Reconstruction | Number of Participants With Side Effects | 25 Participants |
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
Time frame: 2 hours post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1-Knee Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Score | 5.2 score on a scale | Standard Deviation 1.8 |
| Group 2-Knee Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Score | 5.3 score on a scale | Standard Deviation 2.2 |
| Group 1-ACL Reconstruction | Numeric Pain Rating Scale (NPRS) Pain Score | 5.0 score on a scale | Standard Deviation 2.7 |
| Group 2-ACL Reconstruction | Numeric Pain Rating Scale (NPRS) Pain Score | 5.6 score on a scale | Standard Deviation 2.2 |
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
Time frame: 7 days post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1-Knee Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 2.0 score on a scale | Standard Deviation 1.8 |
| Group 2-Knee Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 2.4 score on a scale | Standard Deviation 2.3 |
| Group 1-ACL Reconstruction | Numeric Pain Rating Scale (NPRS) Pain Scores | 2.9 score on a scale | Standard Deviation 2 |
| Group 2-ACL Reconstruction | Numeric Pain Rating Scale (NPRS) Pain Scores | 2.6 score on a scale | Standard Deviation 1.8 |
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
Time frame: 48 hours post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1-Knee Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 3.0 score on a scale | Standard Deviation 2.1 |
| Group 2-Knee Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 3.5 score on a scale | Standard Deviation 0.4 |
| Group 1-ACL Reconstruction | Numeric Pain Rating Scale (NPRS) Pain Scores | 4.2 score on a scale | Standard Deviation 2.2 |
| Group 2-ACL Reconstruction | Numeric Pain Rating Scale (NPRS) Pain Scores | 4.6 score on a scale | Standard Deviation 2.2 |
Opiate Count
Number Pills Taken
Time frame: 7 days post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1-Knee Arthroscopy | Opiate Count | 3.5 Pills Hydrocodone/Acetaminophen 10/325mg | Standard Deviation 6.3 |
| Group 2-Knee Arthroscopy | Opiate Count | 4.5 Pills Hydrocodone/Acetaminophen 10/325mg | Standard Deviation 6 |
| Group 1-ACL Reconstruction | Opiate Count | 9.5 Pills Hydrocodone/Acetaminophen 10/325mg | Standard Deviation 10 |
| Group 2-ACL Reconstruction | Opiate Count | 12.2 Pills Hydrocodone/Acetaminophen 10/325mg | Standard Deviation 14.2 |
Opiate Count
24 hours post-op
Time frame: 24 hours post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1-Knee Arthroscopy | Opiate Count | 1.4 pills | Standard Deviation 1.8 |
| Group 2-Knee Arthroscopy | Opiate Count | 1.6 pills | Standard Deviation 1.6 |
| Group 1-ACL Reconstruction | Opiate Count | 2.5 pills | Standard Deviation 2.2 |
| Group 2-ACL Reconstruction | Opiate Count | 3.6 pills | Standard Deviation 2.4 |
Opiate Count
48 hours post-op
Time frame: 48 hours post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1-Knee Arthroscopy | Opiate Count | 2.1 pills | Standard Deviation 2.8 |
| Group 2-Knee Arthroscopy | Opiate Count | 2.5 pills | Standard Deviation 2.8 |
| Group 1-ACL Reconstruction | Opiate Count | 4.8 pills | Standard Deviation 4.4 |
| Group 2-ACL Reconstruction | Opiate Count | 6.0 pills | Standard Deviation 3.9 |
Refill Requests
Number of participants requesting opioid refills within 3 months after surgery
Time frame: Within 3 months after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1-Knee Arthroscopy | Refill Requests | 1 Participants |
| Group 2-Knee Arthroscopy | Refill Requests | 0 Participants |
| Group 1-ACL Reconstruction | Refill Requests | 5 Participants |
| Group 2-ACL Reconstruction | Refill Requests | 7 Participants |
Side Effects
48 hours post-op
Time frame: 48 hours post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1-Knee Arthroscopy | Side Effects | 7 Participants |
| Group 2-Knee Arthroscopy | Side Effects | 5 Participants |
| Group 1-ACL Reconstruction | Side Effects | 24 Participants |
| Group 2-ACL Reconstruction | Side Effects | 25 Participants |
Side Effects, 24 Hours Post-op
Number of Participants with Side Effects, 24 hours post-op
Time frame: 24 hours post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1-Knee Arthroscopy | Side Effects, 24 Hours Post-op | 7 Participants |
| Group 2-Knee Arthroscopy | Side Effects, 24 Hours Post-op | 5 Participants |
| Group 1-ACL Reconstruction | Side Effects, 24 Hours Post-op | 23 Participants |
| Group 2-ACL Reconstruction | Side Effects, 24 Hours Post-op | 24 Participants |
Still Taking Opiates?
Number of patients who took any opiates between 1 day and 2 days postoperative
Time frame: 2 days postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1-Knee Arthroscopy | Still Taking Opiates? | No | 23 Participants |
| Group 1-Knee Arthroscopy | Still Taking Opiates? | Yes | 25 Participants |
| Group 2-Knee Arthroscopy | Still Taking Opiates? | No | 28 Participants |
| Group 2-Knee Arthroscopy | Still Taking Opiates? | Yes | 19 Participants |
| Group 1-ACL Reconstruction | Still Taking Opiates? | No | 10 Participants |
| Group 1-ACL Reconstruction | Still Taking Opiates? | Yes | 33 Participants |
| Group 2-ACL Reconstruction | Still Taking Opiates? | No | 9 Participants |
| Group 2-ACL Reconstruction | Still Taking Opiates? | Yes | 33 Participants |
Still Taking Opiates?
Number of patients who took any opiates between surgery and 1 day postoperative
Time frame: 1 day postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1-Knee Arthroscopy | Still Taking Opiates? | Yes | 38 Participants |
| Group 1-Knee Arthroscopy | Still Taking Opiates? | No | 10 Participants |
| Group 2-Knee Arthroscopy | Still Taking Opiates? | No | 17 Participants |
| Group 2-Knee Arthroscopy | Still Taking Opiates? | Yes | 30 Participants |
| Group 1-ACL Reconstruction | Still Taking Opiates? | Yes | 38 Participants |
| Group 1-ACL Reconstruction | Still Taking Opiates? | No | 5 Participants |
| Group 2-ACL Reconstruction | Still Taking Opiates? | Yes | 39 Participants |
| Group 2-ACL Reconstruction | Still Taking Opiates? | No | 3 Participants |
Still Taking Opiates?
Number of patients who took any opiates between 7 days and 21 days postoperative
Time frame: 21 days postoperatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1-Knee Arthroscopy | Still Taking Opiates? | Yes | 3 Participants |
| Group 1-Knee Arthroscopy | Still Taking Opiates? | No | 45 Participants |
| Group 2-Knee Arthroscopy | Still Taking Opiates? | No | 47 Participants |
| Group 2-Knee Arthroscopy | Still Taking Opiates? | Yes | 0 Participants |
| Group 1-ACL Reconstruction | Still Taking Opiates? | Yes | 5 Participants |
| Group 1-ACL Reconstruction | Still Taking Opiates? | No | 38 Participants |
| Group 2-ACL Reconstruction | Still Taking Opiates? | Yes | 5 Participants |
| Group 2-ACL Reconstruction | Still Taking Opiates? | No | 37 Participants |
Still Taking Opiates?
Number of patients who took any opiates between 2 days and 7 days postoperative
Time frame: 7 days postoperatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1-Knee Arthroscopy | Still Taking Opiates? | Yes | 18 Participants |
| Group 1-Knee Arthroscopy | Still Taking Opiates? | No | 30 Participants |
| Group 2-Knee Arthroscopy | Still Taking Opiates? | No | 30 Participants |
| Group 2-Knee Arthroscopy | Still Taking Opiates? | Yes | 17 Participants |
| Group 1-ACL Reconstruction | Still Taking Opiates? | Yes | 29 Participants |
| Group 1-ACL Reconstruction | Still Taking Opiates? | No | 14 Participants |
| Group 2-ACL Reconstruction | Still Taking Opiates? | Yes | 31 Participants |
| Group 2-ACL Reconstruction | Still Taking Opiates? | No | 11 Participants |