5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Sur… (NCT06232577) | Clinical Trial Compass
Active — Not RecruitingPhase 2
5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial
United States170 participantsStarted 2024-03-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year