5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial
Running, not enrolling · Phase 2
Conditions studied: Intra-abdominal Cancer
In brief
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.
Key facts
- Study ID
- NCT06232577
- Run by
- M.D. Anderson Cancer Center
- People needed
- 170
- Starts
- 2024-03-27
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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