Knee InjuriesNCT03876743
Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction
A study testing Group 1-Knee Arthroscopy, Group 2-Knee Arthroscopy and Group 1-ACL reconstruction in people with Knee Injuries and ACL Injury, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Knee Injuries, ACL Injury
- What is being tested?
- Group 1-Knee Arthroscopy, Group 2-Knee Arthroscopy and Group 1-ACL reconstruction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2018to 8 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Pregnant women
- Prisoners
- Patients currently taking narcotics, chronic pain management patients, history of substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medicine Department of Orthopaedic Surgery
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Injuries, ACL Injury
- Being tested
- Group 1-Knee Arthroscopy, Group 2-Knee Arthroscopy, Group 1-ACL reconstruction, Group 2-ACL reconstruction
- Medical subject headings
- Knee Injuries, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1-Knee ArthroscopyOther
Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
Group 2-Knee ArthroscopyOther
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 1-ACL reconstructionOther
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstructionOther
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Knee Arthroscopy | Experimental | Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected. Receives: Other: Group 1-Knee Arthroscopy |
| Group 2-Knee Arthroscopy | Experimental | 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. Receives: Other: Group 2-Knee Arthroscopy |
| Group 1-ACL reconstruction | Experimental | Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. Receives: Other: Group 1-ACL reconstruction |
| Group 2-ACL reconstruction | Experimental | Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. Receives: Other: Group 2-ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours post-op
Opiate Count
24 hours post-op
Measured: 24 hours post-op
Side Effects, 24 Hours Post-op
Number of Participants with Side Effects, 24 hours post-op
Measured: 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
Measured: 48 hours post-op
Opiate Count
48 hours post-op
Measured: 48 hours post-op
Side Effects
48 hours post-op
Measured: 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
Measured: 7 days post-op
Opiate Count
Number Pills Taken
Measured: 7 days post-op
Number of Participants With Side Effects
Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation
Measured: 7 days post-op
Refill Requests
Number of participants requesting opioid refills within 3 months after surgery
Measured: Within 3 months after surgery
Still Taking Opiates?
Number of patients who took any opiates between surgery and 1 day postoperative
Measured: 1 day postoperative
Still Taking Opiates?
Number of patients who took any opiates between 1 day and 2 days postoperative
Measured: 2 days postoperative
Still Taking Opiates?
Number of patients who took any opiates between 2 days and 7 days postoperative
Measured: 7 days postoperatively
Still Taking Opiates?
Number of patients who took any opiates between 7 days and 21 days postoperative
Measured: 21 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start26 Mar 2018
- Primary completion23 Mar 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vehniah Tjong, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876743
- Sponsor's protocol ID
- STU00206152
- Status last verified
- Sep 2020
- First submitted
- 20 Mar 2018
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32755488
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Many Opiates Should we Prescribe for Pain in Patients Undergoing Knee Arthroscopies and ACL Reconstructions?
- ClinicalTrials.gov ID
- NCT03876743
- Acronym / sponsor ID
- STU00206152
- Conditions
- Knee Injuries, ACL Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1-Knee Arthroscopy | Experimental | Other: Group 1-Knee ArthroscopyWill have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected. |
| Group 2-Knee Arthroscopy | Experimental | Other: Group 2-Knee ArthroscopyWill 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 1-ACL reconstruction | Experimental | Other: Group 1-ACL reconstructionWill be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. |
| Group 2-ACL reconstruction | Experimental | Other: Group 2-ACL reconstructionWill be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1-Knee ArthroscopyWill 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 |
| Group 2-Knee ArthroscopyWill 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 |
| Group 1-ACL reconstructionWill be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. | Other | Group 1-ACL reconstruction |
| Group 2-ACL reconstructionWill be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. | Other | Group 2-ACL reconstruction |
Primary outcome
Numeric Pain Rating Scale (NPRS) Pain Score
Time frame: 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
Time frame: 24 hours post-op
24 hours post-op
Side Effects, 24 Hours Post-op
Time frame: 24 hours post-op
Number of Participants with Side Effects, 24 hours post-op
Numeric Pain Rating Scale (NPRS) Pain Scores
Time frame: 48 hours post-op
48 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Opiate Count
Time frame: 48 hours post-op
48 hours post-op
Side Effects
Time frame: 48 hours post-op
48 hours post-op
Numeric Pain Rating Scale (NPRS) Pain Scores
Time frame: 7 days post-op
7 days post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Opiate Count
Time frame: 7 days post-op
Number Pills Taken
Number of Participants With Side Effects
Time frame: 7 days post-op
Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation
Refill Requests
Time frame: Within 3 months after surgery
Number of participants requesting opioid refills within 3 months after surgery
Still Taking Opiates?
Time frame: 1 day postoperative
Number of patients who took any opiates between surgery and 1 day postoperative
Still Taking Opiates?
Time frame: 2 days postoperative
Number of patients who took any opiates between 1 day and 2 days postoperative
Still Taking Opiates?
Time frame: 7 days postoperatively
Number of patients who took any opiates between 2 days and 7 days postoperative
Still Taking Opiates?
Time frame: 21 days postoperatively
Number of patients who took any opiates between 7 days and 21 days postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32755488Hartwell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1-Knee Arthroscopy, Group 2-Knee Arthroscopy and Group 1-ACL reconstruction in people with Knee Injuries and ACL Injury, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) Pain Score (time frame: 2 hours post-op). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03876743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.