5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial
NCT ID: NCT06232577
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
170 participants
INTERVENTIONAL
2024-03-27
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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5x-Multiplier Model
In this group, you will be given 5 times the amount of opioid medication you needed on your last day in the hospital. You would then use this supply plus standard non-narcotic pain medications.
Hydrocodone
Given by PO
Tramadol
Given by PO
Oxycodone
Given by PO
3-Tier Model
The total amount of opioid medication you needed on your last day in the hospital to set a maximum number of opioid medications at discharge (up to 30).
Hydrocodone
Given by PO
Tramadol
Given by PO
Oxycodone
Given by PO
Interventions
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Hydrocodone
Given by PO
Tramadol
Given by PO
Oxycodone
Given by PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ching-Wei D Tzeng, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Fields BC, Newhook TE, Lillemoe HA, Qiao W, Karam JA, Matin SF, Meyer LA, Tzeng CD. 5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-Abdominal Cancer Surgery: Randomized Clinical Trial Protocol. Adv Cancer Educ Qual Improv. 2025;1(1):19. doi: 10.52519/aceqi.25.1.1.a19.
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2024-00632
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0818
Identifier Type: -
Identifier Source: org_study_id