Clinical trial · Interventional
5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial
NCT06232577CI-TRIAL-00111516completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intra-abdominal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrocodone | Drug | — | UNRESOLVED |
| Oxycodone | Drug | — | UNRESOLVED |
| Tramadol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 5x-Multiplier Model
- description
- 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.
- interventionNames
- Drug: Hydrocodone
- Drug: Tramadol
- Drug: Oxycodone
- type
- EXPERIMENTAL
- label
- 3-Tier Model
- description
- 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).
- interventionNames
- Drug: Hydrocodone
- Drug: Tramadol
- Drug: Oxycodone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFields 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. PMID 40583965