Opioid UseNCT03570320
Does Altering Narcotic Prescription Methods Affect Opioid Distribution Following Select Upper Extremity Surgeries?
A study testing Modification of opioid prescription method in people with Opioid Use, run by John Yanik at 1 site in United States.
Trial summary
It has been well established that prescription opioid misuse and prescription opioid abuse is on the rise. In the late 1990's and early 2000's, there was a large push to make "pain" the fifth vital sign. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- Modification of opioid prescription method
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 29 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients at the University of Iowa Hospitals and Clinics will be eligible for this study if they are over the age of 18 and are undergoing outpatient ORIF of isolated unilateral distal radius fractures or first CMC joint arthroplasty.
Who cannot join
- Patients will be excluded if they are undergoing surgery for an infection, receiving revision surgery, have multiple injuries that require narcotic use, have a history of chronic narcotic use, or cannot provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
It has been well established that prescription opioid misuse and prescription opioid abuse is on the rise. In the late 1990's and early 2000's, there was a large push to make "pain" the fifth vital sign. At the same time, direct-to-consumer advertising and changes in national guidelines laid the groundwork for a decade that would ultimately see the amount of narcotic prescriptions in the United States more than double, and the number of prescription-opioid related deaths more than quadruple.
Recently, providers have started to question their own role in this epidemic. In the field of orthopedics in particular, considerable emphasis is now being placed on developing a better understanding of patients postoperative pain requirements, and amending practices to continue to meet those requirements while at the same time responsibly limiting the amount of narcotics that are prescribed. The goal of this project is to further this line of research by testing an opioid prescription model that is designed to easily reconcile clinical practices for prescribing pain medications with individual patient needs.
Read more
The investigators propose to evaluate a new method for prescribing opioid pain medications that consists of giving patients smaller amounts of narcotics with easier access to refills. It is hypothesized that in this system, patients will ultimately obtain fewer pills from the pharmacy, and will have fewer pills left over following their post-operative recovery. To test this hypothesis, a randomized controlled trial has been designed wherein patients will be given either one single prescription for opioid medications (control group, representing current practice) or multiple small prescriptions for opioid medications that they may fill on an as-needed basis (intervention group). The total amount of narcotics prescribed to both groups will be the same; only the number of prescriptions and the size of each prescription will be altered.
Unused narcotic medications are ripe for diversion and may potentially be playing a significant role in the opioid abuse crisis that we are experiencing in the United States. Developing strategies to minimize left over pills while maintaining adequate pain control is perhaps one of the most crucial first steps in addressing this important issue. The success of this model could have broad implications across the healthcare profession. From surgery to emergency medicine and even primary care, this model would be easy to implement and may provide an effective way for the medical community to start to combat the opioid epidemic.
Read the detailed description
The investigators propose to evaluate a method for prescribing opioid pain medications in the acute post-operative period. This approach consists of giving patients smaller amounts of narcotics with easier access to refills. The investigators hypothesize that in this system, patients will ultimately obtain fewer pills from the pharmacy, and will have fewer pills left over following their post-operative recovery. To test this hypothesis, a randomized controlled trial has been designed. The investigators have chosen patients undergoing open reduction and internal fixation of distal radius fractures and patients undergoing first carpometacarpal joint arthroplasty as the study population. In the literature, the investigators experience, anecdotally, and as was demonstrated with a brief informal survey that was collected, these groups of patients have similar opioid needs postoperatively, and that need is relatively high when compared to other hand and upper extremity surgeries.
Intervention:
Patients will be consented on the day of surgery. Patients who consent in the preoperative area will be sequentially randomized to one of two treatment groups. The first treatment group will be the control arm. On discharge following their surgery, these patients will receive a single prescription for 225 Morphine Milligram Equivalents (MMEs). This corresponds to #30 pills of 5mg oxycodone/acetaminophen, #45 pills of 5mg hydrocodone/acetaminophen, or #30 pills of 7.5mg Morphine.
Patients who are randomized into the second group will also receive prescriptions for 225 MME's on discharge following their surgery, however their medications will be broken up equally into 3 separate scripts, each for 75 MME's. This corresponds to 3 scripts for #10 pills of 5mg oxycodone/acetaminophen, 3 scripts for #15 pills of 5mg hydrocodone/acetaminophen, or 3 scripts for #10 pills of 7.5mg Morphine. Each script will be post-dated to ensure that patients wait the appropriate amount of time between filling their scripts, and that they cannot fill multiple scripts on the same day or at the same time. Patient consent, randomization, surgery, and discharge with their scripts will all occur on the day of their operation.
Should a patient call in or come to clinic requesting more narcotic medication, the study policy will be that all patients are eligible to receive additional scripts in increments of 75 MME's regardless of their initial randomized group (an additional #10 pills of 5mg oxycodone/acetaminophen, #15 pills of 5mg Hydrocodone/acetaminophen, or #10 pills of 7.5mg Morphine). The number of additional scripts that patients may receive will be at the discretion of the surgeon who performed the procedure. Patients will have to make separate requests for each additional script - the investigators will not give multiple additional scripts at once. If the physician and patient feel that it is in the patient's best interest, they may transition from one narcotic to another at the time of a refill.
The investigators will assess the patients post-operative narcotic use including the number of pills distributed from the pharmacy to each group, number of pills consumed, and number of pills retained after the patient is no longer requiring them. The investigators will also assess patients general pain control, comfort level, and standard outcomes during the recovery period.
- Conditions
- Opioid Use
- Being tested
- Modification of opioid prescription method
- Keywords
- opioid, narcotic, postoperative, prescription, refill, upper extremity surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modification of opioid prescription methodOther
Patients in the interventional arm of the study will receive post-op opioid medications in three small prescriptions as opposed to one large prescription. They may fill these prescriptions as needed.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The first treatment group will be our control arm. On discharge following their surgery, these patients will receive a single prescription for 225 Morphine Milligram Equivalents (MMEs). This corresponds to #30 pills of 5mg oxycodone/acetaminophen, #45 pills of 5mg hydrocodone/acetaminophen, or #30 pills of 7.5mg Morphine. |
| Interventional Arm | Experimental | Patients who are randomized into the second group will also receive prescriptions for 225 MME's on discharge following their surgery, however their medications will be broken up equally into 3 separate scripts, each for 75 MME's. This corresponds to 3 scripts for #10 pills of 5mg oxycodone/acetaminophen, 3 scripts for #15 pills of 5mg hydrocodone/acetaminophen, or 3 scripts for #10 pills of 7.5mg Morphine. Each script will be post-dated to ensure that patients wait the appropriate amount of time between filling their scripts, and that they cannot fill multiple scripts on the same day or at the same time. Receives: Other: Modification of opioid prescription method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pills dispensed from a pharmacy to patients
Investigators will track how many pills were dispensed from a pharmacy to patients in each group.
Measured: For each patient, this outcome will be assessed out to 8 weeks postoperatively or when the patient is no longer requiring pain medications.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start4 Sep 2018
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- 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
- Model description
- Control arm versus interventional arm
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Yanik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Yanik, University of Iowa
- Investigators
- John M Yanik, MD, Principal investigator, University of Iowa Hospitals and Clinics, Department of Orthopedics and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570320
- Sponsor's protocol ID
- 201804820
- Status last verified
- Mar 2020
- First submitted
- 15 Jun 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790.
PubMed 29343479Caudill-Slosberg MA, Schwartz LM, Woloshin S. Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000. Pain. 2004 Jun;109(3):514-519. doi: 10.1016/j.pain.2004.03.006.
PubMed 15157714Clark DJ, Schumacher MA. America's Opioid Epidemic: Supply and Demand Considerations. Anesth Analg. 2017 Nov;125(5):1667-1674. doi: 10.1213/ANE.0000000000002388.
PubMed 29049112Dwyer MK, Tumpowsky CM, Hiltz NL, Lee J, Healy WL, Bedair HS. Characterization of Post-Operative Opioid Use Following Total Joint Arthroplasty. J Arthroplasty. 2018 Mar;33(3):668-672. doi: 10.1016/j.arth.2017.10.011. Epub 2017 Oct 16.
PubMed 29128235Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Med Care. 2016 Oct;54(10):901-6. doi: 10.1097/MLR.0000000000000625.
PubMed 27623005Jones CM, Paulozzi LJ, Mack KA. Sources of prescription opioid pain relievers by frequency of past-year nonmedical use United States, 2008-2011. JAMA Intern Med. 2014 May;174(5):802-3. doi: 10.1001/jamainternmed.2013.12809. No abstract available.
PubMed 24589763Kim N, Matzon JL, Abboudi J, Jones C, Kirkpatrick W, Leinberry CF, Liss FE, Lutsky KF, Wang ML, Maltenfort M, Ilyas AM. A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing Guidelines. J Bone Joint Surg Am. 2016 Oct 19;98(20):e89. doi: 10.2106/JBJS.15.00614.
PubMed 27869630Levin P. The Opioid Epidemic: Impact on Orthopaedic Surgery. J Am Acad Orthop Surg. 2015 Sep;23(9):e36-7. doi: 10.5435/JAAOS-D-15-00250. Epub 2015 Aug 13. No abstract available.
PubMed 26271757Macintyre PE, Huxtable CA, Flint SL, Dobbin MD. Costs and consequences: a review of discharge opioid prescribing for ongoing management of acute pain. Anaesth Intensive Care. 2014 Sep;42(5):558-74. doi: 10.1177/0310057X1404200504.
PubMed 25233168Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
PubMed 22786464Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.
PubMed 25911660Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.
PubMed 22410178Sabatino MJ, Kunkel ST, Ramkumar DB, Keeney BJ, Jevsevar DS. Excess Opioid Medication and Variation in Prescribing Patterns Following Common Orthopaedic Procedures. J Bone Joint Surg Am. 2018 Feb 7;100(3):180-188. doi: 10.2106/JBJS.17.00672.
PubMed 29406338Soffin EM, Waldman SA, Stack RJ, Liguori GA. An Evidence-Based Approach to the Prescription Opioid Epidemic in Orthopedic Surgery. Anesth Analg. 2017 Nov;125(5):1704-1713. doi: 10.1213/ANE.0000000000002433.
PubMed 29049115Tetrault JM, Butner JL. Non-Medical Prescription Opioid Use and Prescription Opioid Use Disorder: A Review. Yale J Biol Med. 2015 Sep 3;88(3):227-33. eCollection 2015 Sep.
PubMed 26339205
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Altering Narcotic Prescription Methods Affect Opioid Distribution Following Select Upper Extremity Surgeries?
- ClinicalTrials.gov ID
- NCT03570320
- Acronym / sponsor ID
- 201804820
- Conditions
- Opioid Use
- Keywords
- opioid, narcotic, postoperative, prescription, refill, upper extremity surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- John YanikUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 26 Jun 2018 (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.
It has been well established that prescription opioid misuse and prescription opioid abuse is on the rise. In the late 1990's and early 2000's, there was a large push to make "pain" the fifth vital sign. At the same time, direct-to-consumer advertising and changes in national guidelines laid the groundwork for a decade that would ultimately see the amount of narcotic prescriptions in the United States more than double, and the number of prescription-opioid related deaths more than quadruple.
Recently, providers have started to question their own role in this epidemic. In the field of orthopedics in particular, considerable emphasis is now being placed on developing a better understanding of patients postoperative pain requirements, and amending practices to continue to meet those requirements while at the same time responsibly limiting the amount of narcotics that are prescribed. The goal of this project is to further this line of research by testing an opioid prescription model that is designed to easily reconcile clinical practices for prescribing pain medications with individual patient needs.
The investigators propose to evaluate a new method for prescribing opioid pain medications that consists of giving patients smaller amounts of narcotics with easier access to refills. It is hypothesized that in this system, patients will ultimately obtain fewer pills from the pharmacy, and will have fewer pills left over following their post-operative recovery. To test this hypothesis, a randomized controlled trial has been designed wherein patients will be given either one single prescription for opioid medications (control group, representing current practice) or multiple small prescriptions for opioid medications that they may fill on an as-needed basis (intervention group). The total amount of narcotics prescribed to both groups will be the same; only the number of prescriptions and the size of each prescription will be altered.
Unused narcotic medications are ripe for diversion and may potentially be playing a significant role in the opioid abuse crisis that we are experiencing in the United States. Developing strategies to minimize left over pills while maintaining adequate pain control is perhaps one of the most crucial first steps in addressing this important issue. The success of this model could have broad implications across the healthcare profession. From surgery to emergency medicine and even primary care, this model would be easy to implement and may provide an effective way for the medical community to start to combat the opioid epidemic.
Detailed description
The investigators propose to evaluate a method for prescribing opioid pain medications in the acute post-operative period. This approach consists of giving patients smaller amounts of narcotics with easier access to refills. The investigators hypothesize that in this system, patients will ultimately obtain fewer pills from the pharmacy, and will have fewer pills left over following their post-operative recovery. To test this hypothesis, a randomized controlled trial has been designed. The investigators have chosen patients undergoing open reduction and internal fixation of distal radius fractures and patients undergoing first carpometacarpal joint arthroplasty as the study population. In the literature, the investigators experience, anecdotally, and as was demonstrated with a brief informal survey that was collected, these groups of patients have similar opioid needs postoperatively, and that need is relatively high when compared to other hand and upper extremity surgeries.
Intervention:
Patients will be consented on the day of surgery. Patients who consent in the preoperative area will be sequentially randomized to one of two treatment groups. The first treatment group will be the control arm. On discharge following their surgery, these patients will receive a single prescription for 225 Morphine Milligram Equivalents (MMEs). This corresponds to #30 pills of 5mg oxycodone/acetaminophen, #45 pills of 5mg hydrocodone/acetaminophen, or #30 pills of 7.5mg Morphine.
Patients who are randomized into the second group will also receive prescriptions for 225 MME's on discharge following their surgery, however their medications will be broken up equally into 3 separate scripts, each for 75 MME's. This corresponds to 3 scripts for #10 pills of 5mg oxycodone/acetaminophen, 3 scripts for #15 pills of 5mg hydrocodone/acetaminophen, or 3 scripts for #10 pills of 7.5mg Morphine. Each script will be post-dated to ensure that patients wait the appropriate amount of time between filling their scripts, and that they cannot fill multiple scripts on the same day or at the same time. Patient consent, randomization, surgery, and discharge with their scripts will all occur on the day of their operation.
Should a patient call in or come to clinic requesting more narcotic medication, the study policy will be that all patients are eligible to receive additional scripts in increments of 75 MME's regardless of their initial randomized group (an additional #10 pills of 5mg oxycodone/acetaminophen, #15 pills of 5mg Hydrocodone/acetaminophen, or #10 pills of 7.5mg Morphine). The number of additional scripts that patients may receive will be at the discretion of the surgeon who performed the procedure. Patients will have to make separate requests for each additional script - the investigators will not give multiple additional scripts at once. If the physician and patient feel that it is in the patient's best interest, they may transition from one narcotic to another at the time of a refill.
The investigators will assess the patients post-operative narcotic use including the number of pills distributed from the pharmacy to each group, number of pills consumed, and number of pills retained after the patient is no longer requiring them. The investigators will also assess patients general pain control, comfort level, and standard outcomes during the recovery period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control arm versus interventional arm
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The first treatment group will be our control arm. On discharge following their surgery, these patients will receive a single prescription for 225 Morphine Milligram Equivalents (MMEs). This corresponds to #30 pills of 5mg oxycodone/acetaminophen, #45 pills of 5mg hydrocodone/acetaminophen, or #30 pills of 7.5mg Morphine. |
| Interventional Arm | Experimental | Other: Modification of opioid prescription methodPatients who are randomized into the second group will also receive prescriptions for 225 MME's on discharge following their surgery, however their medications will be broken up equally into 3 separate scripts, each for 75 MME's. This corresponds to 3 scripts for #10 pills of 5mg oxycodone/acetaminophen, 3 scripts for #15 pills of 5mg hydrocodone/acetaminophen, or 3 scripts for #10 pills of 7.5mg Morphine. Each script will be post-dated to ensure that patients wait the appropriate amount of time between filling their scripts, and that they cannot fill multiple scripts on the same day or at the same time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at the University of Iowa Hospitals and Clinics will be eligible for this study if they are over the age of 18 and are undergoing outpatient ORIF of isolated unilateral distal radius fractures or first CMC joint arthroplasty.
Key exclusion criteria (1 listed)
- Patients will be excluded if they are undergoing surgery for an infection, receiving revision surgery, have multiple injuries that require narcotic use, have a history of chronic narcotic use, or cannot provide informed 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 |
|---|---|---|
| Modification of opioid prescription methodPatients in the interventional arm of the study will receive post-op opioid medications in three small prescriptions as opposed to one large prescription. They may fill these prescriptions as needed. | Other | Interventional Arm |
Primary outcome
Number of pills dispensed from a pharmacy to patients
Time frame: For each patient, this outcome will be assessed out to 8 weeks postoperatively or when the patient is no longer requiring pain medications.
Investigators will track how many pills were dispensed from a pharmacy to patients in each group.
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 24 Mar 2020.
- Background: PubMed 29343479Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790.
- Background: PubMed 15157714Caudill-Slosberg MA, Schwartz LM, Woloshin S. Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000. Pain. 2004 Jun;109(3):514-519. doi: 10.1016/j.pain.2004.03.006.
- Background: PubMed 29049112Clark DJ, Schumacher MA. America's Opioid Epidemic: Supply and Demand Considerations. Anesth Analg. 2017 Nov;125(5):1667-1674. doi: 10.1213/ANE.0000000000002388.
- Background: PubMed 29128235Dwyer MK, Tumpowsky CM, Hiltz NL, Lee J, Healy WL, Bedair HS. Characterization of Post-Operative Opioid Use Following Total Joint Arthroplasty. J Arthroplasty. 2018 Mar;33(3):668-672. doi: 10.1016/j.arth.2017.10.011. Epub 2017 Oct 16.
- Background: PubMed 27623005Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Med Care. 2016 Oct;54(10):901-6. doi: 10.1097/MLR.0000000000000625.
- Background: PubMed 24589763Jones CM, Paulozzi LJ, Mack KA. Sources of prescription opioid pain relievers by frequency of past-year nonmedical use United States, 2008-2011. JAMA Intern Med. 2014 May;174(5):802-3. doi: 10.1001/jamainternmed.2013.12809. No abstract available.
- Background: PubMed 27869630Kim N, Matzon JL, Abboudi J, Jones C, Kirkpatrick W, Leinberry CF, Liss FE, Lutsky KF, Wang ML, Maltenfort M, Ilyas AM. A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing Guidelines. J Bone Joint Surg Am. 2016 Oct 19;98(20):e89. doi: 10.2106/JBJS.15.00614.
- Background: PubMed 26271757Levin P. The Opioid Epidemic: Impact on Orthopaedic Surgery. J Am Acad Orthop Surg. 2015 Sep;23(9):e36-7. doi: 10.5435/JAAOS-D-15-00250. Epub 2015 Aug 13. No abstract available.
- Background: PubMed 25233168Macintyre PE, Huxtable CA, Flint SL, Dobbin MD. Costs and consequences: a review of discharge opioid prescribing for ongoing management of acute pain. Anaesth Intensive Care. 2014 Sep;42(5):558-74. doi: 10.1177/0310057X1404200504.
- Background: PubMed 22786464Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
- Background: PubMed 25911660Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.
- Background: PubMed 22410178Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.
- 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.
John M Yanik, MD principal investigator
University of Iowa Hospitals and Clinics, Department of Orthopedics and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modification of opioid prescription method in people with Opioid Use, run by John Yanik 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 24 Mar 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?
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?
Number of pills dispensed from a pharmacy to patients (time frame: For each patient, this outcome will be assessed out to 8 weeks postoperatively or when the patient is no longer requiring pain medications.). 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 NCT03570320, which also lists 15 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 24 Mar 2020.