Study for Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 18-004216
NCT ID: NCT03805386
Sponsor Protocol Number: 18-004216
About this study
The purpose of this study is to evaluate the impact of patient input on opioid prescribing and overall opioid use following gynecologic surgery.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Female patients >18 years old.
- Ability to provide informed consent.
- Planned minimally invasive hysterectomy with the Department of Surgery.
- 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:
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Johnny Yi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available