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

2023-0818

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.

2024-03-27

2024-07-01

2026-07-01

Recruiting

Early phase I

150

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-05-07