Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery

Completed · Phase 2/Phase 3

Conditions studied: Gynecology, Surgery, Opioid Use

In brief

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.

Key facts

Study ID

NCT03805386

Run by

Mayo Clinic

People needed

65

Starts

2019-01-15

Expected to finish

2020-04-15

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.