Clinical trial NCT03805386: Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery
Official title: Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gynecology
Surgery
Opioid Use
Keywords: patient directed postoperative opioid prescribing
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: # of Opioid Pills Consumed
timeFrame: 6 weeks postop
Secondary outcomes:
measure: Opioid Pills Prescribed
timeFrame: preoperative visit
measure: Patient Satisfaction
timeFrame: 6 weeks post-operative
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Johnny Yi
role: PRINCIPAL_INVESTIGATOR
References: