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.
Additional locations may be listed 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
