Phase 3
N=65
Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery
Gynecology · Surgery · Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT03805386 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: # of Opioid Pills Consumed — 26.7; 38.4 % oxycodone used
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Physician directed opioid prescribing (Drug); Patient directed opioid prescribing (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY # of Opioid Pills Consumed |
26.7; 38.4 | — |
| SECONDARY Opioid Pills Prescribed |
30; 15 | — |
| SECONDARY Patient Satisfaction |
27; 29 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03805386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.