Intra-abdominal Cancer
Conditions
Brief summary
To compare 2 different models for prescribing opioid pain medication to provide better pain control to participants with an abdominal cancer who are having surgery.
Detailed description
Primary Objectives: The co-primary objectives of this study are as follows: 1\. To determine differences in the initial OME prescribed upon discharge between each algorithm/model. 1\. To determine OME usage by day 14 after hospital discharge. Secondary Objectives: Secondary objectives are as follows: 1. To determine rates of patients with zero OME upon discharge. 2. To determine rates of OME refill requests and completions at 15- and 30-days post-operation. 3. To determine number of unused or leftover pills at 15- and 30-days post- operation 4. To determine persistent opioid use at 30-days, 3-months, and 6-months post-operation 5. To elucidate patient, prescriber, and oncologic factors predictive of persistent opioid use 6. To assess quality of life using patient-reported outcomes at 30-days, 3-months, and 6-months post-operation. 7. To determine patient satisfaction with either prescribing model.
Interventions
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants ≥18 years of age * Participants undergoing any of the following abdominal surgeries on an elective basis at MD Anderson Cancer Center: * Open pancreatectomy * Open hepatectomy * Open resection of retroperitoneal sarcoma * Open nephrectomy * Open cytoreductive surgery (in ovarian cancer) * Participants with a planned inpatient admission of at least 48 hours after surgery * Opioid-naive patients who use less than or equal to 7.5 mg OME per day (on average) during the 30 days prior to consent * Participants able to understand and willing to sign an informed consent document * English and non-English-speaking participants
Exclusion criteria
* Participants requiring non-elective (emergent or urgent) surgery will be excluded * Participants with a current or previous history of substance abuse disorder, including alcohol or drugs * Participants prescribed long-acting chronic pain medications * Participants using hydromorphone or fentanyl or under the care of a chronic pain specialist * Participants unable or unwilling to participate in follow-up study requirements (e.g., QOL surveys, opioid log) * Participants discharged on palliative or hospice care * Participants with a history of allergic reactions to opioids * Participants enrolled in any other opioid discharge protocol * Participants who are pregnant * Participants who are cognitively impaired
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChing-Wei D Tzeng, MD
M.D. Anderson Cancer Center
Outcome results
None listed