NCT06232577

5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intra-abdominal Cancer

Interventions

Type	Name	Description
DRUG	Hydrocodone	Given by PO
DRUG	Tramadol	Given by PO
DRUG	Oxycodone	Given by PO

Timeline

• Start date: 2024-03-27
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2024-01-31
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study