NCT03805386

Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Physician directed opioid prescribing	Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.
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.

Timeline

• Start date: 2019-01-15
• Primary completion: 2020-04-15
• Completion: 2020-04-15
• First posted: 2019-01-15
• Last updated: 2021-02-21
• Results posted: 2021-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study