This phase II trial compares the effect of the 5x-Mulitplier Model to the 3-Tier Model for prescribing opioid pain medication to provide better pain control in patients with an abdominal cancer undergoing surgery. The increase in annual opioid prescriptions over time is a known contributor to the stark rates of opioid dependence and overdose deaths in the United States. Opioids make up more than one-third of all surgeon-prescribed medications, providing up to 10% of total opioid prescriptions across all medical specialties. In fact, in the oncology realm, up to 15% of patients that have not had opioids before become persistent opioid users after surgery. Interventions to reduce post-operative prescriptions of opioids have been shown to have no adverse effects on pain control. The 5x-Multiplier Model prescribes 5 times the amount of opioids used in the past 24 hours while the 3-Tier Model calculates the total amount used the prior 24 hours to set the maximum number of opioids prescribed. The 5x-Multiplier Model may decrease the amount of opioids prescribed after discharge compared to the 3-Tier Model in patients with abdominal cancer undergoing surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06232577.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Temporarily closed to accrual
Contact: Ching-Wei David Tzeng
Phone: 713-792-6940
PRIMARY OBJECTIVES:
I. To determine differences in the initial oral morphine equivalents (OME) prescribed upon discharge between each algorithm/model.
II. To determine OME usage by day 14 after hospital discharge.
SECONDARY OBJECTIVES:
I. To determine rates of patients with zero OME upon discharge.
II. To determine rates of OME refill requests and completions at 15- and 30-days post-operation.
III. To determine number of unused or leftover pills at 15- and 30-days post- operation.
IV. To determine persistent opioid use at 30-days, 3-months, and 6-months post-operation.
V. To elucidate patient, prescriber, and oncologic factors predictive of persistent opioid use.
VI. To assess quality of life using patient-reported outcomes at 30-days, 3-months, and 6-months post operation.
VII. To determine patient satisfaction with either prescribing model.
OUTLINE: Patients are randomized at discharge to 1 of 2 arms.
ARM I: Patients undergo scheduled abdominal surgery and receive standard of care scheduled non-narcotic pain medications and 5x-Multiplier Model dosing of standard of care opioid at discharge.
ARM II: Patients undergo scheduled abdominal surgery and receive standard of care scheduled non-narcotic pain medications and 3-Tier Model dosing of standard of care opioid at discharge.
After completion of study treatment, patients are followed up at 14 or 30 days and at 3 and 6 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorChing-Wei David Tzeng
