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Completed

NCT Number: NCT03805386

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physician directed opioid prescribing

Drug

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

Patient directed opioid prescribing

Drug

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

Primary outcomes

  1. # of Opioid Pills Consumed

    Time frame: 6 weeks postop

    Percent utilization of opioids consumed (consumed/prescribed)

Secondary outcomes

  1. Opioid Pills Prescribed

    Time frame: preoperative visit

    Number of opioids prescribed

  2. Patient Satisfaction

    Time frame: 6 weeks post-operative

    Patients were asked if they were satisfied with the # of oxycodone pills prescribed.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 15, 2019
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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