Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Opioid Use; Gynecology
• Intervention / Treatment: Drug: Physician directed opioid prescribing; Drug: Patient directed opioid prescribing

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria

• Female patients >18 years old
• Ability to provide informed consent
• Planned minimally invasive hysterectomy with the Department of Gynecology 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; 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.	Drug: Physician directed opioid prescribing; Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.
Experimental: Patient Directed Care; 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.	Drug: Patient directed opioid prescribing; Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
# of Opioid Pills Consumed	Percent utilization of opioids consumed (consumed/prescribed)	6 weeks postop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Pills Prescribed	Number of opioids prescribed	preoperative visit
Patient Satisfaction	Patients were asked if they were satisfied with the # of oxycodone pills prescribed.	6 weeks post-operative

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Johnny Yi, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): April 15, 2020
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: January 12, 2019
• First Submitted That Met QC Criteria: January 12, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: patient directed postoperative opioid prescribing
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 18-004216

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No