Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery

NCT03805386 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 18-004216
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecology; Surgery; Opioid Use

Keywords

patient directed postoperative opioid prescribing

Outcome Measures

Primary Outcomes (1)

• # of Opioid Pills Consumed

  Percent utilization of opioids consumed (consumed/prescribed)

  6 weeks postop

Secondary Outcomes (2)

• Opioid Pills Prescribed

  preoperative visit

• Patient Satisfaction

  6 weeks post-operative

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Drug: Physician directed opioid prescribing

Patient Directed Care

EXPERIMENTAL

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.

Drug: Patient directed opioid prescribing

Interventions

Physician directed opioid prescribing DRUG

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

Standard of Care

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.

Patient Directed Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Principal Investigator, Dr Johnny Yi
• Organization: Mayo Clinic Arizona

yi.johnny@mayo.edu

14803420612

Study Officials

• Johnny Yi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: January 12, 2019
• First Posted: January 15, 2019
• Study Start: January 15, 2019
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-01

Locations

US (1)