Does Altering Narcotic Prescription Methods Affect Opioid Distribution Following Select Upper Extremity Surgeries?
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2018 |
| Start Date: | September 4, 2018 |
| End Date: | February 28, 2020 |
| Contact: | John M Yanik, MD |
| Email: | john-yanik@uiowa.edu |
| Phone: | 319-356-2223 |
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.
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.
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.
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.
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.
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