Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery

Surgery Clinical Trial

Official title:

Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805386
• Other study ID #: 18-004216
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 15, 2019
• Est. completion date: April 15, 2020

Study information

• Verified date: January 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecology
• Opioid Use
• Surgery

Intervention

Drug:
• Physician directed opioid prescribing
Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.
• Patient directed opioid prescribing
Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	# of Opioid Pills Consumed	Percent utilization of opioids consumed (consumed/prescribed)	6 weeks postop
Secondary	Opioid Pills Prescribed	Number of opioids prescribed	preoperative visit
Secondary	Patient Satisfaction	Patients were asked if they were satisfied with the # of oxycodone pills prescribed.	6 weeks post-operative

External Links

•   Mayo Clinic Clinical Trials