Opioid UseNCT04083209
Effect of Preoperative Counseling on Postoperative Opioid Use Following Knee Arthroscopy.
A study testing Opioid counseling in people with Opioid Use and Opioid-use Disorder, run by Indiana University at 1 site in United States.
Trial summary
Our study looks to evaluate the effect of brief preoperative counseling on opioid use following knee arthroscopy. We aim to quantify the effect we have as providers in changing patient behavior postoperatively in terms of the type and amount of pain medication that is utilized. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Opioid-use Disorder
- What is being tested?
- Opioid counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 26 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-60, undergoing knee arthroscopic meniscectomy surgery
Who cannot join
- Non-english speaking, prisoners, those who cannot provide consent on their own, previous history of chronic opioid use, prior history of surgery on the ipsilateral knee, and those undergoing additional surgical procedures on the same knee at the time of the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Counseling on Postoperative Opioid Use Following Knee Arthroscopy. A Randomized Controlled Trial.
Our study looks to evaluate the effect of brief preoperative counseling on opioid use following knee arthroscopy. We aim to quantify the effect we have as providers in changing patient behavior postoperatively in terms of the type and amount of pain medication that is utilized.
Read the detailed description
Amid a national opioid epidemic, providers are looking for ways to minimize the utilization of narcotic and addictive pain medications while adequately treating acute and postoperative pain, all the while maintaining patient satisfaction. Much effort has been dedicated to studying non-narcotic alternative medications such as acetaminophen, NSAIDs, toradol, ketamine, ect., as well as multimodal strategies such as periaxial and perineural blockades. Little attention, however, has been given to the role we play as providers to help minimize the use of these addictive medications and the potential effect we have on changing patient behaviors. Alter et al1 published in the Journal of Hand Surgery their success of minimizing opioid use by simple preoperative counseling of patients undergoing carpal tunnel release surgery. They provided brief educational materials about the opioid epidemic and risks of these medications, as well as encouraging patients to utilize non-narcotic alternatives to control pain postoperatively. They saw a decrease in the amount of opioids used with no difference in pain scores in the group receiving this preoperative counseling.
There are roughly 750,000 knee scopes performed each year in the United States. The incidence of chronic opioid use stemming from a short course of narcotics after elective knee arthroscopy has been shown to be up to 30%.2-4 The high volume of these procedures presents a unique opportunity to study trends in opioid use and pain control in the postoperative period in a prospective fashion.
Study Design
Patients scheduled to undergo knee arthroscopy by a single surgeon will be randomized into preoperative counseling or no counseling by simple randomization methods (computer generated "coin flip"). Those in the counseling group will receive a two minute talk during their preoperative appointment covering the risks of opioid medications, current public health situation regarding opioids, and alternative methods for pain control. They will also receive a one page document summarizing the Pennsylvania Orthopedic Society recommendations regarding opioid use that was used in previous research1. All patients will be prescribed the same pain medication and quantity (hydrocodone-acetaminophen 5-325 mg, 40 pills, 0 refills). Postoperatively, patients will be contacted via telephone on postoperative day three, asking what medication and how many pills they are taking daily for pain, as well as rating their daily pain level on a scale from 0-10. At their first postoperative follow-up appointment, they will again be asked about the quantity of pain medications used and pain level. After the first postoperative phone call, all data collection will be obtained at their regularly scheduled postoperative office visits, which occur at two and four weeks postoperatively. During all postoperative data collection time points we will also inquire and note all pain control measures, including ice, heat, compression, elevation, or other medications not commonly thought of as "pain medications". Data collection from each patient will be concluded at their one month postoperative visit.
- Conditions
- Opioid Use, Opioid-use Disorder
- Being tested
- Opioid counseling
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid counselingBehavioural
The formal opioid counseling will involve reading the recommendations for postoperative opioid use established by the Pennsylvania Orthopedic Society.
| Study group | Role | What they receive |
|---|---|---|
| Counseling group | Experimental | Patients randomized into the "counseling group" will be given a 1-2 minute presentation over the risks of opioid pain medications during their preoperative visit. Receives: Behavioral: Opioid counseling |
| Control group | No intervention | The control group will undergo the standard preoperative evaluation by the senior author without any additional formal opioid counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of opioid pain medication used
Patients will be tracked for the amount of opioid pain medication that is used during their postoperative course using a pill log.
Measured: 2 weeks
Secondary outcomes (1)
VAS pain scores
Patients will also be surveyed on their pain level postoperatively using the VAS pain scale. The scale is from 0-10 with 10 being the highest amount of pain. 0 representing no pain.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start15 Oct 2019
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients will be randomized into a treatment and control group.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Gerald Klitzman, Indiana University
- Investigators
- Mitch Beckert, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083209
- Sponsor's protocol ID
- 1001
- Status last verified
- May 2021
- First submitted
- 6 Sep 2019
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share all data collected from the study including non-identifiable patient demographics, pain scores, opioid medication utilization, complications, and study design.
Publications
Tepolt FA, Bido J, Burgess S, Micheli LJ, Kocher MS. Opioid Overprescription After Knee Arthroscopy and Related Surgery in Adolescents and Young Adults. Arthroscopy. 2018 Dec;34(12):3236-3243. doi: 10.1016/j.arthro.2018.07.021. Epub 2018 Nov 2.
PubMed 30396797Rozet I, Nishio I, Robbertze R, Rotter D, Chansky H, Hernandez AV. Prolonged opioid use after knee arthroscopy in military veterans. Anesth Analg. 2014 Aug;119(2):454-459. doi: 10.1213/ANE.0000000000000292.
PubMed 24977636Alter TH, Ilyas AM. A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Carpal Tunnel Release Surgery. J Hand Surg Am. 2017 Oct;42(10):810-815. doi: 10.1016/j.jhsa.2017.07.003. Epub 2017 Sep 8.
PubMed 28890331
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Counseling on Postoperative Opioid Use Following Knee Arthroscopy. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04083209
- Acronym / sponsor ID
- 1001
- Conditions
- Opioid Use, Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study looks to evaluate the effect of brief preoperative counseling on opioid use following knee arthroscopy. We aim to quantify the effect we have as providers in changing patient behavior postoperatively in terms of the type and amount of pain medication that is utilized.
Detailed description
Amid a national opioid epidemic, providers are looking for ways to minimize the utilization of narcotic and addictive pain medications while adequately treating acute and postoperative pain, all the while maintaining patient satisfaction. Much effort has been dedicated to studying non-narcotic alternative medications such as acetaminophen, NSAIDs, toradol, ketamine, ect., as well as multimodal strategies such as periaxial and perineural blockades. Little attention, however, has been given to the role we play as providers to help minimize the use of these addictive medications and the potential effect we have on changing patient behaviors. Alter et al1 published in the Journal of Hand Surgery their success of minimizing opioid use by simple preoperative counseling of patients undergoing carpal tunnel release surgery. They provided brief educational materials about the opioid epidemic and risks of these medications, as well as encouraging patients to utilize non-narcotic alternatives to control pain postoperatively. They saw a decrease in the amount of opioids used with no difference in pain scores in the group receiving this preoperative counseling.
There are roughly 750,000 knee scopes performed each year in the United States. The incidence of chronic opioid use stemming from a short course of narcotics after elective knee arthroscopy has been shown to be up to 30%.2-4 The high volume of these procedures presents a unique opportunity to study trends in opioid use and pain control in the postoperative period in a prospective fashion.
Study Design
Patients scheduled to undergo knee arthroscopy by a single surgeon will be randomized into preoperative counseling or no counseling by simple randomization methods (computer generated "coin flip"). Those in the counseling group will receive a two minute talk during their preoperative appointment covering the risks of opioid medications, current public health situation regarding opioids, and alternative methods for pain control. They will also receive a one page document summarizing the Pennsylvania Orthopedic Society recommendations regarding opioid use that was used in previous research1. All patients will be prescribed the same pain medication and quantity (hydrocodone-acetaminophen 5-325 mg, 40 pills, 0 refills). Postoperatively, patients will be contacted via telephone on postoperative day three, asking what medication and how many pills they are taking daily for pain, as well as rating their daily pain level on a scale from 0-10. At their first postoperative follow-up appointment, they will again be asked about the quantity of pain medications used and pain level. After the first postoperative phone call, all data collection will be obtained at their regularly scheduled postoperative office visits, which occur at two and four weeks postoperatively. During all postoperative data collection time points we will also inquire and note all pain control measures, including ice, heat, compression, elevation, or other medications not commonly thought of as "pain medications". Data collection from each patient will be concluded at their one month postoperative visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized into a treatment and control group.
| Arm | Type | Receives |
|---|---|---|
| Counseling group | Experimental | Behavioral: Opioid counselingPatients randomized into the "counseling group" will be given a 1-2 minute presentation over the risks of opioid pain medications during their preoperative visit. |
| Control group | No intervention | –The control group will undergo the standard preoperative evaluation by the senior author without any additional formal opioid counseling. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 18-60, undergoing knee arthroscopic meniscectomy surgery
Key exclusion criteria (1 listed)
- Non-english speaking, prisoners, those who cannot provide consent on their own, previous history of chronic opioid use, prior history of surgery on the ipsilateral knee, and those undergoing additional surgical procedures on the same knee at the time of the surgery
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 |
|---|---|---|
| Opioid counselingThe formal opioid counseling will involve reading the recommendations for postoperative opioid use established by the Pennsylvania Orthopedic Society. | Behavioural | Counseling group |
Primary outcome
Quantity of opioid pain medication used
Time frame: 2 weeks
Patients will be tracked for the amount of opioid pain medication that is used during their postoperative course using a pill log.
1 secondary outcome
VAS pain scores
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Results publication: PubMed 30396797Tepolt FA, Bido J, Burgess S, Micheli LJ, Kocher MS. Opioid Overprescription After Knee Arthroscopy and Related Surgery in Adolescents and Young Adults. Arthroscopy. 2018 Dec;34(12):3236-3243. doi: 10.1016/j.arthro.2018.07.021. Epub 2018 Nov 2.
- Results publication: PubMed 24977636Rozet I, Nishio I, Robbertze R, Rotter D, Chansky H, Hernandez AV. Prolonged opioid use after knee arthroscopy in military veterans. Anesth Analg. 2014 Aug;119(2):454-459. doi: 10.1213/ANE.0000000000000292.
- Results publication: PubMed 28890331Alter TH, Ilyas AM. A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Carpal Tunnel Release Surgery. J Hand Surg Am. 2017 Oct;42(10):810-815. doi: 10.1016/j.jhsa.2017.07.003. Epub 2017 Sep 8.
- Individual participant dataSharing planned: Undecided. We plan to share all data collected from the study including non-identifiable patient demographics, pain scores, opioid medication utilization, complications, and study design.
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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.
Mitch Beckert, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid counseling in people with Opioid Use and Opioid-use Disorder, run by Indiana 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 1 inclusion and 1 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 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantity of opioid pain medication used (time frame: 2 weeks). 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 NCT04083209, which also lists 3 linked publications.
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 May 2021.