Clinical trial NCT03805386
Conditions: Gynecology Surgery Opioid Use
Keywords: patient directed postoperative opioid prescribing
Sponsor: Mayo Clinic
Start date: 2019-01-15; Completion date: 2020-04-15
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We would like to evaluate and optimize opioid prescribing after minimally invasive hysterectomy. Currently, our standard prescribing is 150 oral morphine equivalents. However, recent studies show that half of the opioids prescribed are not used. We would like to include the patient in the decision making of the opioid prescribing.

We have designed a randomized controlled trial to prescribe standard (150 oral morphine equivalents) or patient directed (less than or equal to 150 oral morphine equivalents) for pain control.

We hypothesize that with patient input, there will be a higher utilization of the opioids prescribed. Also, we anticipate a lower number of opioids used overall.

This study will help us optimize opioid prescribe and evaluate whether patient input can help in this important measure.

Detailed description:
There is an emphasis in patient centered care in medicine and part of this effort has evaluated the success of shared decision making in the care of the patient. Currently, there is strong research and clinical emphasis trying to determine how, as surgeons, we can assist in minimizing the misuse of opioid medications. Several studies have shown significant over-prescribing and under-utilizing of the pain medications that are prescribed to patients after surgery. One such study by As-Sanie et al showed that about half of medications were utilized for pain after surgery, with typically 200 oral morphine equivalents prescribed.

A recent prospective cohort study by Prabhu et al showed that shared decision making in the prescription of narcotic pain medications after cesarean section decreased opioid use without impacting patient satisfaction.

We propose a randomized controlled trial evaluating the impact of shared decision making in the prescribing of pain medications after minimally invasive gynecologic surgery. For adult female patients who are undergoing minimally invasive hysterectomy, we will randomize them to either standard care or patient directed treatment. Our standard arm will receive 150 oral morphine equivalents, or 30 tablets of oxycodone, whereas our patient directed arm will receive a prescription with as many pills is determined after discussion with the patient.

We hope to contribute to identifying the optimized opioid prescription for post surgical patients.

Arms: arm 1: Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. arm 2: Subject directed arm will be prescribed the number of opioids that the patient decides to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.
Interventions: intervention 1: Physician directed opioid prescribing intervention 2: Patient directed opioid prescribing
Intervention descriptions: intervention 1: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. intervention 2: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.

Protocol documents:
Prot_SAP_000.pdf: 
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Mayo Clinic in Arizona (AZ) Small Grants Protocol Submission Template 
 
Title of the study: Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery 
 
 
 
Principal investigator: Johnny Yi, MD 
 
 
Co-investigator(s):  Ritchie Mae Delara, MD, Sadikah Behbehani, MD, Rachael Haverland, MD, 
Mohammad Islam, MD, Megan Wasson, DO 
 
IRB# 18-004216 
 
Date:  September 4, 2018 (Initial version) 
            Revised October 29, 2018 
 
 
 
FORMAT:  Please limit the entire application to 2 single-spaced pages using one-inch (1") 
margins, Times New Roman, 12 pt. font size.  Protocols not adhering to these guidelines are 
subject to being returned without review. 
 
Abstract 
Opioids are commonly prescribed after major gynecologic surgery, such as hysterectomy.  While they 
may improve pain control for moderate to severe pain, this must be weighed against the existing and 
worsening opioid epidemic in the United States. Factors that affect a surgeon’s prescribing patterns may 
include experience, patient’s pre-existing pain, and mode of surgery.  Furthermore, protocols may exist 
for the number of narcotics prescribed for the type of surgery performed.  Missing from the decision tree 
of prescribing narcotics is patient input. The current study is a prospective randomized, clinical trial 
evaluating the impact of patient input on opioid prescribing and overall opioid use following gynecologic 
surgery. 
 
Research Plan 
I. Specific Aims 
 
Hypothesis:  In women who undergo minimally invasive hysterectomy, those who provide input into the 
number of opioids prescribed are statistically significantly more likely to have high utilization of the 
narcotics prescribed. 
o Primary Outcome:  Patients randomized to patient directed arm will have a lower 
percentage of unused opioids as compared to those prescribed standard therapy. 
o Secondary Outcomes:   
▪ Patients randomized to patient directed arm will use less narcotics overall as 
compared to those prescribed standard therapy. 
▪ Patients randomized to patient-directed arm will be more likely to be satisfied 
with their post-operative pain management as compared to those prescribed 
standard therapy. 
 
II. Background and Significance  
Opioids are commonly prescribed after major gynecologic surgery, such as a hysterectomy.  While they 
may improve pain control for moderate to severe pain, this must be weighed against the existing and 
worsening opioid epidemic in the United States.  There is a strong movement to minimize narcotics, by 
reviewing and optimizing the prescriptions prescribed, especially after surgery.  As-Sanie et al evaluated 
common narcotic prescribing patterns following benign hysterectomy in Michigan and the authors found 


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that typically 200 oral morphine equivalents are prescribed, while only about half of the medications 
were actually used.[1]  A recent survey study performed at a tertiary care center in Massachusetts 
evaluated opioids prescribing patterns and patient opioid consumption after gynecologic surgery found 
that patients used less than half of prescribed opioids, and a fraction did not use opioids at all.[2] 
 
Factors that affect a surgeon’s prescribing patterns may include physician experience, patient’s pre-
existing pain, and mode of surgery.  Furthermore, protocols may exist for the number of narcotics 
prescribed for the type of surgery performed.  Missing from the decision tree of prescribing narcotics is 
patient input.  Shared-decision making has been shown to improve patient outcomes and patient 
satisfaction in several clinical settings.[3-5]  A Cochrane review of 105 randomized control trials 
documented that the use of patient decision aids for preference-sensitive decisions led to patients feeling 
more clear about what matters to them and having more accurate expectations of benefits and harms of 
options.[6]  
 
A prospective cohort study evaluating shared decision-making intervention on acute pain management 
after cesarean delivery showed a reduction in opioid utilization in 50% of their patient cohort and 
significant patient satisfaction in regards to their outpatient pain management.[7]  Currently no studies 
have evaluated patient-directed input to narcotic prescriptions following surgery.  Including the patient 
into this decision tree may help optimize the narcotics prescribed and provides some accountability to 
the patient since they helped make the decision. 
 
A national survey showed that most adolescents and adults reported recent non-medical use of opioid 
medications being obtained through family or friends.[8] By decreasing the number of opioids 
prescribed to patients, we could decrease the number of opioid medication sharing and potentially 
prevent unsafe opioid disposal practices. 
 
III. Research Design and Methods 
   
Study Design 
We propose a prospective randomized, clinical trial evaluating the impact on opioid prescribing and 
overall opioid use following gynecologic surgery.  Patients will be recruited if they are undergoing 
minimally invasive hysterectomy with the Department of Gynecology.  If they meet the inclusion criteria, 
patients will be randomized to standard treatment or patient-directed treatment.  They will be followed per 
standard postoperative care of the surgeon, and at the last postoperative visit, the remaining opioids will be 
collected and counted.   
 
Currently, the Department of Gynecology’s standard approach to hysterectomy is in a minimally invasive 
modality - vaginal, laparoscopic, or robotic.  These surgeries are typically performed as an outpatient 
surgery with same day discharge, unless other medical co-morbidities exist or clinical status necessitates 
postoperative inpatient admission.  Patients undergoing minimally invasive hysterectomy, with or without 
other gynecologic procedures, are discharged home with 150 oral morphine equivalents, or 30 tablets of 
oxycodone.  Patients also receive 40 tablets of ibuprofen 600 mg and 40 tablets of 500 mg acetaminophen. 
Patients are informed that they can take ibuprofen 600 mg up to four times daily, acetaminophen 1000 mg 
up to four times daily (or up to 4000 mg/day), and oxycodone 5-10 mg every 4 hours as needed for severe 
pain.   
 
Patient-directed opioid prescribing will take place after randomization for this arm of patients.  They will 
continue to receive prescriptions for ibuprofen and acetaminophen as standard therapy. There will be a 
discussion with the patient during the preoperative appointment as to the number of tablets (oxycodone 5 
mg) they wold like prescribed, from 0 to 30 tablets.  A standard verbal script discussing the pros and cons 


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of opioid use will be utilized for this informed decision.  This will be documented in the preoperative 
clinic note and appropriate prescription will be provided to the patient on the day of surgery. 
 
Study Subjects 
Patients will be recruited from the Department of Gynecology.  They will be screened if they are 
undergoing minimally invasive hysterectomy.  Those who meet inclusion and exclusion criteria will be 
approached for enrollment.  Once enrolled, the patient will undergo randomization to standard therapy 
or patient-directed therapy.  Prescription of opioids in the patient-directed therapy arm will have an 
upper limit of 150 oral morphine equivalents, which is the standard therapy dose.  However, they will be 
free to choose a lower number of pills.   
 
Inclusion criteria 
• 
Female patients >18 years old 
• 
Ability to provide informed consent 
• 
Planned minimally invasive hysterectomy with the Department of Surgery 
o Concomitant minimally invasive surgeries performed by Gynecology will be allowed 
Exclusion criteria 
• Non-English speaking 
• Combined surgical cases with other surgical departments 
• Planned laparotomy 
• Surgery planned to last >4 hours 
• Postoperative hospitalization planned for >7 days 
• Planned use of oral opioids other than oxycodone postoperatively 
• Pre-existing 
chronic 
pain 
conditions 
including: 
chronic 
pelvic 
pain, 
migraines, 
temporomandibular joint dysfunction syndrome, fibromyalgia, and interstitial cystitis 
• Preoperative diagnosis of pelvic pain 
• Chronic preoperative opioid use 
• History of or current diagnosis of narcotic or alcohol dependence 
o Screening question asked at preoperative appointment:  Have you or are you currently 
dependent on narcotic medications or alcohol? 
• Desire for more opioids than standard therapy 
• Postoperative decision of surgeon to prescribed more than standard therapy 
• Allergy or contraindication to taking opioids, ibuprofen, or acetaminophen 
 
Sample Size 
We will enroll patients until 216, assuming 20% patients either have missing data or dropout the study for 
any reason, which are 172 subjects. A smaple size of 86 in each group will achieve 90% power to detect 
the medium effect size of 0.5 by using two-sided two-sample t-test with 0.05 significance level. 
 
Subject Randomization 
The patients will be randomized into two groups, standard therapy arm and patient-directed arm. The 
block randomization method will be used to ensure balance in sample size between groups. 
 
Data Collection 
Demographic information will be collected, which will include age, race, BMI.  The surgical procedure 
performed will also be collected, along with the length of hospitalization.  Type, strength and quantity of 
opioids prescribed for all patients will be documented.  Refills on opioids that are required or other 
medications that are prescribed for pain will also be documented through chart review.   
 


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On the day of discharge from the hospital, patient will be provided with a pill diary by the study team. The 
patient will be instructed to document the date and time any pain medication was taken; the number of 
oxycodone, ibuprofen, and/or acetaminophen pills consumed during that time; and their pain level prior to 
taking the oxycodone. Pain will be measured using an 11-point numeric scale ranging from 0 to 10. Zero 
will represent one pain extreme (i.e., “no pain”) and 10 will represent the other pain extreme (i.e., “pain as 
bad as you can imagine” or “worst pain imaginable”). Patient will be asked to complete the pill diary as 
long as they are taking pain medication post-operatively. 
 
At their 6-week postoperative visit, patients will be asked to bring in their pill diary and remaining pain 
medications so that any excess pills can be counted and documented.  If the patient has more than one 
postoperative visit, they will be encouraged to bring their pill bottle at the 6-week postoperative visit. At 
their 6-week post-operative visit, patients will be asked how satisfied they are with the number of narcotic 
pills they were initially prescribed, and they will rate their satisfaction using a 5-point numeric scale 
ranging from 1 to 5. One will represent one satisfaction extreme (i.e. “not at all satisfied”), 3 will be 
neutral (i.e., “neither dissatisfied nor satisfied), and 5 will represent the other satisfaction extreme (“i.e., 
extremely satisfied”). Those patients who forget or are unable to bring their medication with them to the 6-
week postoperative visit will be asked to count their own remaining medication and report this on a follow 
up phone call with the study team. The patient satisfaction questionnaire may also be administered during 
this follow up phone call if the patient was not able to complete this at the postoperative visit. 
 
Statistical Analysis 
Descriptive analysis will be performed to summarize demographic and clinical characteristics of the 
patients. We will compare the percentage of utilization of opioid between the two groups by two-sample t-
test. We will do further analysis using Analysis of Variance and Covariance (ANCOVA) to compare the 
utilization between the two groups after adjusting patient characteristics if needed. 
 
 
IV. Human Subjects 
Human subjects will be utilized for this protocol. As with all research, there is a chance that 
confidentiality could be compromised; however, precautions will be taken to minimize this risk. Patient 
identification codes will be used. A number will be assigned to all subjects and any report published will 
not identify the subjects by name. Data will be stored on password-protected computers. 
 
 
VII. References:  
 
1. 
As-Sanie, S., et al., Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy 
for Benign Indications. Obstet Gynecol, 2017. 130(6): p. 1261-1268. 
2. 
Griffith, K., et al., Opioid Prescription and Patient use After Gynecologic Procedures: A Survey of 
Patients and Providers. J Minim Invasive Gynecol, 2018. 25(4):684-688. 
3. 
Clever, S., et al., Primary Care Patients' Involvement in Decision-Making Is Associated With 
Improvement in Depression. Med Care, 2006. 44:398-405. 
4. 
Loh, A., et al., The Impact of Patient Participation  on Adherence and Clinical Outcome in Primary Care 
of Depression. Patient Educ Couns. 2007;65:69-78. 
5. 
Loh, A., et al., The Effects of a Shared Decision-Making Intervention in Primary Care of Depression: A 
Cluster Randomized Controlled Trial. Patient Educ Couns. 2007;67:324-332. 
6. 
Stacey, D., et al., Decision Aids for People Facing Health Treatment or Screening Decisions. Cochrane 
Database of Systemic Reviews, 2017. 


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7. 
Prabhu, M., et al, A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean 
Delivery. Obstet Gynecol, 2017. 130(1): 42-46. 
8. 
Kennedy-Hendricks, A., et al., Medication Sharing, Storage, and Disposal Practices for Opioid 
Medications Among US Adults. JAMA Internal Medicine, 2016. 176(7): 1027-1029.. 
 
VIII. Other: 
 
Budget:  A specific budget will be prepared by a Sponsored Project Specialist in the Office of 
Sponsored Projects Administration (OSPA), if this project is chosen for funding.  Small Grant awards 
provide up to $15,000 in direct costs for one year. This mechanism does not support Category 1 time or 
costs for editing/publishing or travel. Typical examples of funding include time for research coordinator 
oversight, supplies, or costs associated with the Survey Center.  
For this program, possible uses of funds may be the following (please indicate what might be relevant to 
this project): 
□ Design/printing surveys or other forms.  Specify quantity____________ 
□ Data collection and data entry.  Specify the person(s) you intend to have responsible for these 
activities.  ___________________________________________________________________ 
□ Statistical analysis.  
□ Other.  Please describe_________________________________________________________ 
 
Progress Report:  At the conclusion of the year, a progress report should be prepared that clearly 
and unambiguously addresses the following issues: 
• 
Describe the progress that has been made toward achieving the stated aims of the proposal, 
including all publications and presentations resulting from this work. 
• 
Describe the preliminary data and its significance. 
• 
Provide a clear timeline for the completion of each major task necessary to complete the 
study. 
• 
Describe plans for obtaining support for future research projects.