Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery

NCT ID: NCT03805386

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2020-04-15

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.

Conditions

Gynecology; Surgery; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Physician directed opioid prescribing

Intervention Type: DRUG

Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.

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.

Group Type: EXPERIMENTAL

Patient directed opioid prescribing

Intervention Type: DRUG

Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.

Interventions

Physician directed opioid prescribing

Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Johnny Yi

Prinicpal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johnny Yi

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

18-004216

Identifier Type: -

Identifier Source: org_study_id