An interventional study of Group 1-Knee Arthroscopy and Group 2-Knee Arthroscopy in Knee Injuries and ACL Injury, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by Northwestern University · Not applicable, Interventional, and Other
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.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 201 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Other: Group 1-ACL reconstruction
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Other: Group 2-ACL reconstruction
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.
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
Opiate Count
24 hours post-op
Time frame: 24 hours post-op
Side Effects, 24 Hours Post-op
Number of Participants with Side Effects, 24 hours post-op
Time frame: 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
Time frame: 48 hours post-op
Opiate Count
48 hours post-op
Time frame: 48 hours post-op
Side Effects
48 hours post-op
Time frame: 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
Time frame: 7 days post-op
Opiate Count
Number Pills Taken
Time frame: 7 days post-op
Number of Participants With Side Effects
Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation
Time frame: 7 days post-op
Refill Requests
Number of participants requesting opioid refills within 3 months after surgery
Time frame: Within 3 months after surgery
Still Taking Opiates?
Number of patients who took any opiates between surgery and 1 day postoperative
Time frame: 1 day postoperative
Still Taking Opiates?
Number of patients who took any opiates between 1 day and 2 days postoperative
Time frame: 2 days postoperative
Still Taking Opiates?
Number of patients who took any opiates between 2 days and 7 days postoperative
Time frame: 7 days postoperatively
Still Taking Opiates?
Number of patients who took any opiates between 7 days and 21 days postoperative
Time frame: 21 days postoperatively
| Milestone | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2(30)-ACL Reconstruction |
|---|---|---|---|---|
| Started | 54 | 51 | 46 | 50 |
| Completed | 48 | 47 | 42 | 43 |
| Not completed | 6 | 4 | 4 | 7 |
| Withdrew: Lost to follow-up | 6 | 4 | 4 | 7 |
2 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
| score on a scale | Group 1-Knee Arthroscopy | Group 2-Knee Arthroscopy | Group 1-ACL Reconstruction | Group 2-ACL Reconstruction |
|---|---|---|---|---|
| Numeric Pain Rating Scale (NPRS) Pain Score | 5.2 ± 1.8 | 5.3 ± 2.2 | 5.0 ± 2.7 | 5.6 ± 2.2 |
24 hours post-op
| pills | Group 1-Knee Arthroscopy | Group 2-Knee Arthroscopy | Group 1-ACL Reconstruction | Group 2-ACL Reconstruction |
|---|---|---|---|---|
| Opiate Count | 1.4 ± 1.8 | 1.6 ± 1.6 | 2.5 ± 2.2 | 3.6 ± 2.4 |
Number of Participants with Side Effects, 24 hours post-op
| Participants | Group 1-Knee Arthroscopy | Group 2-Knee Arthroscopy | Group 1-ACL Reconstruction | Group 2-ACL Reconstruction |
|---|---|---|---|---|
| Side Effects, 24 Hours Post-op | 7 | 5 | 23 | 24 |
48 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
| score on a scale | Group 1-Knee Arthroscopy | Group 2-Knee Arthroscopy | Group 1-ACL Reconstruction | Group 2-ACL Reconstruction |
|---|---|---|---|---|
| Numeric Pain Rating Scale (NPRS) Pain Scores | 3.0 ± 2.1 | 3.5 ± .4 | 4.2 ± 2.2 | 4.6 ± 2.2 |
48 hours post-op
| pills | Group 1-Knee Arthroscopy | Group 2-Knee Arthroscopy | Group 1-ACL Reconstruction | Group 2-ACL Reconstruction |
|---|---|---|---|---|
| Opiate Count | 2.1 ± 2.8 | 2.5 ± 2.8 | 4.8 ± 4.4 | 6.0 ± 3.9 |
48 hours post-op
| Participants | Group 1-Knee Arthroscopy | Group 2-Knee Arthroscopy | Group 1-ACL Reconstruction | Group 2-ACL Reconstruction |
|---|---|---|---|---|
| Side Effects | 7 | 5 | 24 | 25 |
7 days post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
| score on a scale | Group 1-Knee Arthroscopy | Group 2-Knee Arthroscopy | Group 1-ACL Reconstruction | Group 2-ACL Reconstruction |
|---|---|---|---|---|
| Numeric Pain Rating Scale (NPRS) Pain Scores | 2.0 ± 1.8 | 2.4 ± 2.3 | 2.9 ± 2.0 | 2.6 ± 1.8 |
Number Pills Taken
| Pills Hydrocodone/Acetaminophen 10/325mg | Group 1-Knee Arthroscopy | Group 2-Knee Arthroscopy | Group 1-ACL Reconstruction | Group 2-ACL Reconstruction |
|---|---|---|---|---|
| Opiate Count | 3.5 ± 6.3 | 4.5 ± 6.0 | 9.5 ± 10.0 | 12.2 ± 14.2 |
Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation
| Participants | Group 1-Knee Arthroscopy | Group 2-Knee Arthroscopy | Group 1-ACL Reconstruction | Group 2-ACL Reconstruction |
|---|---|---|---|---|
| Number of Participants With Side Effects | 7 | 5 | 24 | 25 |
Number of participants requesting opioid refills within 3 months after surgery
| Participants | Group 1-Knee Arthroscopy | Group 2-Knee Arthroscopy | Group 1-ACL Reconstruction | Group 2-ACL Reconstruction |
|---|---|---|---|---|
| Refill Requests | 1 | 0 | 5 | 7 |
Number of patients who took any opiates between surgery and 1 day postoperative
| Participants | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2(30)-ACL Reconstruction |
|---|---|---|---|---|
| Yes | 38 | 30 | 38 | 39 |
| No | 10 | 17 | 5 | 3 |
Number of patients who took any opiates between 1 day and 2 days postoperative
| Participants | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2(30)-ACL Reconstruction |
|---|---|---|---|---|
| Yes | 25 | 19 | 33 | 33 |
| No | 23 | 28 | 10 | 9 |
Number of patients who took any opiates between 2 days and 7 days postoperative
| Participants | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2(30)-ACL Reconstruction |
|---|---|---|---|---|
| Yes | 18 | 17 | 29 | 31 |
| No | 30 | 30 | 14 | 11 |
Number of patients who took any opiates between 7 days and 21 days postoperative
| Participants | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2(30)-ACL Reconstruction |
|---|---|---|---|---|
| Yes | 3 | 0 | 5 | 5 |
| No | 45 | 47 | 38 | 37 |
Collected over 21 days post-surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1-Knee Arthroscopy | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Group 2-Knee Arthroscopy | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Group 1-ACL Reconstruction | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Group 2-ACL Reconstruction | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Age, Categorical(Participants) | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2 (30)-ACL Reconstruction | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 53 | 51 | 46 | 50 | 200 |
| >=65 years | 1 | 0 | 0 | 0 | 1 |
| Age, Continuous(Years) | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2 (30)-ACL Reconstruction | Total |
|---|---|---|---|---|---|
| Mean | 43.8 ± 12.5 | 43.2 ± 13.2 | 33.2 ± 8.9 | 31.3 ± 10.0 | 38.1 ± 12.6 |
| Sex: Female, Male(Participants) | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2 (30)-ACL Reconstruction | Total |
|---|---|---|---|---|---|
| Female | 31 | 20 | 22 | 23 | 96 |
| Male | 23 | 31 | 24 | 27 | 105 |
| Race and Ethnicity Not Collected(Participants) | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2 (30)-ACL Reconstruction | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Body Mass Index(kg/m^2) | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2 (30)-ACL Reconstruction | Total |
|---|---|---|---|---|---|
| Mean | 29.2 ± 7.6 | 29.8 ± 7.9 | 26.4 ± 4.1 | 28.1 ± 6.0 | 28.4 ± 6.7 |
| Are you an active smoker?(Participants) | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2 (30)-ACL Reconstruction | Total |
|---|---|---|---|---|---|
| Yes | 5 | 7 | 1 | 4 | 17 |
| No | 49 | 44 | 45 | 46 | 184 |
| If no, have you ever consistently smoked cigarettes (daily for >1 month)?(Participants) | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2 (30)-ACL Reconstruction | Total |
|---|---|---|---|---|---|
| Yes | 2 | 7 | 4 | 2 | 15 |
| No | 47 | 37 | 41 | 44 | 169 |
| What is your employment status?(Participants) | Group 1 (Filled)-Knee Arthroscopy | Group 2 (as Needed)-Knee Arthroscopy | Group 1 (60)-ACL Reconstruction | Group 2 (30)-ACL Reconstruction | Total |
|---|---|---|---|---|---|
| Employed | 48 | 40 | 39 | 36 | 163 |
| Unemployed | 2 | 6 | 6 | 12 | 26 |
| Disabled | 1 | 2 | 0 | 1 | 4 |
| Retired | 3 | 3 | 1 | 1 | 8 |
8 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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