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Does Altering Narcotic Prescription Methods Affect Opioid Distribution Following Select Upper Extremity Surgeries?

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ClinicalTrials.gov Identifier: NCT03570320
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
John Yanik, University of Iowa

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Opioid Use Other: Modification of opioid prescription method Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Control arm versus interventional arm
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does Altering Narcotic Prescription Methods Affect Opioid Distribution Following Select Upper Extremity Surgeries?
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 28, 2020

Arm Intervention/treatment
No Intervention: Control group
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.
Experimental: Interventional Arm
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.
Other: Modification of opioid prescription method
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570320


Contacts
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Contact: John M Yanik, MD 319-356-2223 john-yanik@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: John M. Yanik, MD    319-353-7585    john-yanik@uiowa.edu   
Sponsors and Collaborators
John Yanik
Investigators
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Principal Investigator: John M Yanik, MD University of Iowa Hospitals and Clinics, Department of Orthopedics and Rehabilitation

Publications:

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Responsible Party: John Yanik, Resident Physician, University of Iowa
ClinicalTrials.gov Identifier: NCT03570320     History of Changes
Other Study ID Numbers: 201804820
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John Yanik, University of Iowa:
opioid
narcotic
postoperative
prescription
refill
upper extremity surgery

Additional relevant MeSH terms:
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Analgesics, Opioid
Acetaminophen, hydrocodone drug combination
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents