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Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03876743
Enrollment
201
Registered
2019-03-15
Start date
2018-03-26
Completion date
2020-07-08
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Injury, Knee Injuries

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

OTHERGroup 1-Knee Arthroscopy

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

OTHERGroup 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.

OTHERGroup 1-ACL reconstruction

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

OTHERGroup 2-ACL reconstruction

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

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Numeric Pain Rating Scale (NPRS) Pain Score2 hours post-op2 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Opiate Count24 hours post-op24 hours post-op
Side Effects, 24 Hours Post-op24 hours post-opNumber of Participants with Side Effects, 24 hours post-op
Numeric Pain Rating Scale (NPRS) Pain Scores48 hours post-op48 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Side Effects48 hours post-op48 hours post-op
Number of Participants With Side Effects7 days post-opPotential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation
Refill RequestsWithin 3 months after surgeryNumber of participants requesting opioid refills within 3 months after surgery
Still Taking Opiates?1 day postoperativeNumber of patients who took any opiates between surgery and 1 day postoperative

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total201

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up6447

Baseline characteristics

CharacteristicGroup 1 (Filled)-Knee ArthroscopyTotalGroup 2 (as Needed)-Knee ArthroscopyGroup 2 (30)-ACL ReconstructionGroup 1 (60)-ACL Reconstruction
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants1 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
53 Participants200 Participants51 Participants50 Participants46 Participants
Age, Continuous43.8 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 Participants113 Participants35 Participants18 Participants20 Participants
Are you actively participating in sporting activities?
Yes
14 Participants88 Participants16 Participants32 Participants26 Participants
Are you an active smoker?
No
49 Participants184 Participants44 Participants46 Participants45 Participants
Are you an active smoker?
Yes
5 Participants17 Participants7 Participants4 Participants1 Participants
Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/Oxycodone) ?
No
54 Participants201 Participants51 Participants50 Participants46 Participants
Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/Oxycodone) ?
Yes
0 Participants0 Participants0 Participants0 Participants0 Participants
At what level (i.e. professional, collegiate, recreational)?
Collegiate
2 Participants10 Participants3 Participants2 Participants3 Participants
At what level (i.e. professional, collegiate, recreational)?
N/A
40 Participants110 Participants35 Participants17 Participants18 Participants
At what level (i.e. professional, collegiate, recreational)?
Professional
0 Participants2 Participants0 Participants2 Participants0 Participants
At what level (i.e. professional, collegiate, recreational)?
Recreational
12 Participants79 Participants13 Participants29 Participants25 Participants
Body Mass Index29.2 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 Participants180 Participants47 Participants44 Participants39 Participants
Do you have a family history of illicit substance abuse?
Yes
4 Participants21 Participants4 Participants6 Participants7 Participants
Do you have a personal history of illicit substance abuse?
No
54 Participants201 Participants51 Participants50 Participants46 Participants
Do you have a personal history of illicit substance abuse?
Yes
0 Participants0 Participants0 Participants0 Participants0 Participants
If no, have you ever consistently smoked cigarettes (daily for >1 month)?
No
47 Participants169 Participants37 Participants44 Participants41 Participants
If no, have you ever consistently smoked cigarettes (daily for >1 month)?
Yes
2 Participants15 Participants7 Participants2 Participants4 Participants
Is this injury part of a workers compensation claim?
No
54 Participants198 Participants50 Participants49 Participants45 Participants
Is this injury part of a workers compensation claim?
Yes
0 Participants3 Participants1 Participants1 Participants1 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
31 Participants96 Participants20 Participants23 Participants22 Participants
Sex: Female, Male
Male
23 Participants105 Participants31 Participants27 Participants24 Participants
What is the highest level of education you have attained?
Completed High School
12 Participants36 Participants7 Participants11 Participants6 Participants
What is the highest level of education you have attained?
Graduate
17 Participants61 Participants18 Participants10 Participants16 Participants
What is the highest level of education you have attained?
Undergraduate
25 Participants104 Participants26 Participants29 Participants24 Participants
What is your average yearly household income?
$100,000 -$149,999
4 Participants31 Participants11 Participants8 Participants8 Participants
What is your average yearly household income?
$150,000 - $199,999
9 Participants15 Participants1 Participants2 Participants3 Participants
What is your average yearly household income?
$200,000 or more
10 Participants32 Participants10 Participants4 Participants8 Participants
What is your average yearly household income?
$20,000 -$34,999
3 Participants7 Participants1 Participants2 Participants1 Participants
What is your average yearly household income?
$35,000 -$49,999
10 Participants26 Participants4 Participants8 Participants4 Participants
What is your average yearly household income?
$50,000 -$74,999
8 Participants42 Participants10 Participants13 Participants11 Participants
What is your average yearly household income?
$75,000 - $99,999
8 Participants32 Participants8 Participants9 Participants7 Participants
What is your average yearly household income?
Less than $20,000
2 Participants16 Participants6 Participants4 Participants4 Participants
What is your employment status?
Disabled
1 Participants4 Participants2 Participants1 Participants0 Participants
What is your employment status?
Employed
48 Participants163 Participants40 Participants36 Participants39 Participants
What is your employment status?
Retired
3 Participants8 Participants3 Participants1 Participants1 Participants
What is your employment status?
Unemployed
2 Participants26 Participants6 Participants12 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 480 / 470 / 430 / 42
other
Total, other adverse events
0 / 480 / 470 / 430 / 42
serious
Total, serious adverse events
0 / 480 / 470 / 430 / 42

Outcome results

Primary

Number of Participants With Side Effects

Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation

Time frame: 7 days post-op

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1-Knee ArthroscopyNumber of Participants With Side Effects7 Participants
Group 2-Knee ArthroscopyNumber of Participants With Side Effects5 Participants
Group 1-ACL ReconstructionNumber of Participants With Side Effects24 Participants
Group 2-ACL ReconstructionNumber of Participants With Side Effects25 Participants
Primary

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

ArmMeasureValue (MEAN)Dispersion
Group 1-Knee ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Score5.2 score on a scaleStandard Deviation 1.8
Group 2-Knee ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Score5.3 score on a scaleStandard Deviation 2.2
Group 1-ACL ReconstructionNumeric Pain Rating Scale (NPRS) Pain Score5.0 score on a scaleStandard Deviation 2.7
Group 2-ACL ReconstructionNumeric Pain Rating Scale (NPRS) Pain Score5.6 score on a scaleStandard Deviation 2.2
Primary

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

ArmMeasureValue (MEAN)Dispersion
Group 1-Knee ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores2.0 score on a scaleStandard Deviation 1.8
Group 2-Knee ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores2.4 score on a scaleStandard Deviation 2.3
Group 1-ACL ReconstructionNumeric Pain Rating Scale (NPRS) Pain Scores2.9 score on a scaleStandard Deviation 2
Group 2-ACL ReconstructionNumeric Pain Rating Scale (NPRS) Pain Scores2.6 score on a scaleStandard Deviation 1.8
Primary

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

ArmMeasureValue (MEAN)Dispersion
Group 1-Knee ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores3.0 score on a scaleStandard Deviation 2.1
Group 2-Knee ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores3.5 score on a scaleStandard Deviation 0.4
Group 1-ACL ReconstructionNumeric Pain Rating Scale (NPRS) Pain Scores4.2 score on a scaleStandard Deviation 2.2
Group 2-ACL ReconstructionNumeric Pain Rating Scale (NPRS) Pain Scores4.6 score on a scaleStandard Deviation 2.2
Primary

Opiate Count

Number Pills Taken

Time frame: 7 days post-op

ArmMeasureValue (MEAN)Dispersion
Group 1-Knee ArthroscopyOpiate Count3.5 Pills Hydrocodone/Acetaminophen 10/325mgStandard Deviation 6.3
Group 2-Knee ArthroscopyOpiate Count4.5 Pills Hydrocodone/Acetaminophen 10/325mgStandard Deviation 6
Group 1-ACL ReconstructionOpiate Count9.5 Pills Hydrocodone/Acetaminophen 10/325mgStandard Deviation 10
Group 2-ACL ReconstructionOpiate Count12.2 Pills Hydrocodone/Acetaminophen 10/325mgStandard Deviation 14.2
Primary

Opiate Count

24 hours post-op

Time frame: 24 hours post-op

ArmMeasureValue (MEAN)Dispersion
Group 1-Knee ArthroscopyOpiate Count1.4 pillsStandard Deviation 1.8
Group 2-Knee ArthroscopyOpiate Count1.6 pillsStandard Deviation 1.6
Group 1-ACL ReconstructionOpiate Count2.5 pillsStandard Deviation 2.2
Group 2-ACL ReconstructionOpiate Count3.6 pillsStandard Deviation 2.4
Primary

Opiate Count

48 hours post-op

Time frame: 48 hours post-op

ArmMeasureValue (MEAN)Dispersion
Group 1-Knee ArthroscopyOpiate Count2.1 pillsStandard Deviation 2.8
Group 2-Knee ArthroscopyOpiate Count2.5 pillsStandard Deviation 2.8
Group 1-ACL ReconstructionOpiate Count4.8 pillsStandard Deviation 4.4
Group 2-ACL ReconstructionOpiate Count6.0 pillsStandard Deviation 3.9
Primary

Refill Requests

Number of participants requesting opioid refills within 3 months after surgery

Time frame: Within 3 months after surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1-Knee ArthroscopyRefill Requests1 Participants
Group 2-Knee ArthroscopyRefill Requests0 Participants
Group 1-ACL ReconstructionRefill Requests5 Participants
Group 2-ACL ReconstructionRefill Requests7 Participants
Primary

Side Effects

48 hours post-op

Time frame: 48 hours post-op

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1-Knee ArthroscopySide Effects7 Participants
Group 2-Knee ArthroscopySide Effects5 Participants
Group 1-ACL ReconstructionSide Effects24 Participants
Group 2-ACL ReconstructionSide Effects25 Participants
Primary

Side Effects, 24 Hours Post-op

Number of Participants with Side Effects, 24 hours post-op

Time frame: 24 hours post-op

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1-Knee ArthroscopySide Effects, 24 Hours Post-op7 Participants
Group 2-Knee ArthroscopySide Effects, 24 Hours Post-op5 Participants
Group 1-ACL ReconstructionSide Effects, 24 Hours Post-op23 Participants
Group 2-ACL ReconstructionSide Effects, 24 Hours Post-op24 Participants
Primary

Still Taking Opiates?

Number of patients who took any opiates between 1 day and 2 days postoperative

Time frame: 2 days postoperative

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1-Knee ArthroscopyStill Taking Opiates?No23 Participants
Group 1-Knee ArthroscopyStill Taking Opiates?Yes25 Participants
Group 2-Knee ArthroscopyStill Taking Opiates?No28 Participants
Group 2-Knee ArthroscopyStill Taking Opiates?Yes19 Participants
Group 1-ACL ReconstructionStill Taking Opiates?No10 Participants
Group 1-ACL ReconstructionStill Taking Opiates?Yes33 Participants
Group 2-ACL ReconstructionStill Taking Opiates?No9 Participants
Group 2-ACL ReconstructionStill Taking Opiates?Yes33 Participants
Primary

Still Taking Opiates?

Number of patients who took any opiates between surgery and 1 day postoperative

Time frame: 1 day postoperative

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1-Knee ArthroscopyStill Taking Opiates?Yes38 Participants
Group 1-Knee ArthroscopyStill Taking Opiates?No10 Participants
Group 2-Knee ArthroscopyStill Taking Opiates?No17 Participants
Group 2-Knee ArthroscopyStill Taking Opiates?Yes30 Participants
Group 1-ACL ReconstructionStill Taking Opiates?Yes38 Participants
Group 1-ACL ReconstructionStill Taking Opiates?No5 Participants
Group 2-ACL ReconstructionStill Taking Opiates?Yes39 Participants
Group 2-ACL ReconstructionStill Taking Opiates?No3 Participants
Primary

Still Taking Opiates?

Number of patients who took any opiates between 7 days and 21 days postoperative

Time frame: 21 days postoperatively

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1-Knee ArthroscopyStill Taking Opiates?Yes3 Participants
Group 1-Knee ArthroscopyStill Taking Opiates?No45 Participants
Group 2-Knee ArthroscopyStill Taking Opiates?No47 Participants
Group 2-Knee ArthroscopyStill Taking Opiates?Yes0 Participants
Group 1-ACL ReconstructionStill Taking Opiates?Yes5 Participants
Group 1-ACL ReconstructionStill Taking Opiates?No38 Participants
Group 2-ACL ReconstructionStill Taking Opiates?Yes5 Participants
Group 2-ACL ReconstructionStill Taking Opiates?No37 Participants
Primary

Still Taking Opiates?

Number of patients who took any opiates between 2 days and 7 days postoperative

Time frame: 7 days postoperatively

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1-Knee ArthroscopyStill Taking Opiates?Yes18 Participants
Group 1-Knee ArthroscopyStill Taking Opiates?No30 Participants
Group 2-Knee ArthroscopyStill Taking Opiates?No30 Participants
Group 2-Knee ArthroscopyStill Taking Opiates?Yes17 Participants
Group 1-ACL ReconstructionStill Taking Opiates?Yes29 Participants
Group 1-ACL ReconstructionStill Taking Opiates?No14 Participants
Group 2-ACL ReconstructionStill Taking Opiates?Yes31 Participants
Group 2-ACL ReconstructionStill Taking Opiates?No11 Participants

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026