Gynecology, Opioid Use, Surgery
Conditions
Keywords
patient directed postoperative opioid prescribing
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.
Interventions
DRUGPhysician directed opioid prescribing
Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.
DRUGPatient directed opioid prescribing
Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| # of Opioid Pills Consumed | 6 weeks postop | Percent utilization of opioids consumed (consumed/prescribed) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 6 weeks post-operative | Patients were asked if they were satisfied with the # of oxycodone pills prescribed. |
| Opioid Pills Prescribed | preoperative visit | Number of opioids prescribed |
Countries
United States
Participant flow
Recruitment details
Ambulatory Gynecologic Surgery Clinic
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care 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.
Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. | 32 |
| Patient Directed Care Subject directed arm will be prescribed the number of opioids that the patient decides based on a shared decision making model 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.
Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care. | 33 |
| Total | 65 |
Baseline characteristics
| Characteristic | Standard of Care | Patient Directed Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 9 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 24 Participants | 44 Participants |
| Age, Continuous | 59.5 years | 52 years | 55 years |
| BMI | 26.3 kg/m2 | 28.3 kg/m2 | 26.9 kg/m2 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 28 Participants | 29 Participants | 57 Participants |
| Region of Enrollment United States | 32 participants | 33 participants | 65 participants |
| Sex: Female, Male Female | 32 Participants | 33 Participants | 65 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 33 |
| other Total, other adverse events | 0 / 32 | 0 / 33 |
| serious Total, serious adverse events | 0 / 32 | 0 / 33 |
Outcome results
Primary
# of Opioid Pills Consumed
Percent utilization of opioids consumed (consumed/prescribed)
Time frame: 6 weeks postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | # of Opioid Pills Consumed | 26.7 % oxycodone used | Standard Error 0.91 |
| Patient Directed Care | # of Opioid Pills Consumed | 38.4 % oxycodone used | Standard Error 1.08 |
Secondary
Opioid Pills Prescribed
Number of opioids prescribed
Time frame: preoperative visit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Opioid Pills Prescribed | 30 pills |
| Patient Directed Care | Opioid Pills Prescribed | 15 pills |
Secondary
Patient Satisfaction
Patients were asked if they were satisfied with the # of oxycodone pills prescribed.
Time frame: 6 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Patient Satisfaction | 27 Participants |
| Patient Directed Care | Patient Satisfaction | 29 Participants |