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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 2

Conditions: Intra-abdominal Cancer

Treatments: Drug: Oxycodone; Drug: Hydrocodone; Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT06232577

2023-0818

NCI-2024-00632 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

2. 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

5x-Multiplier Model

Experimental group

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.

Treatment:

Drug: Tramadol

Drug: Hydrocodone

Drug: Oxycodone

3-Tier Model

Experimental group

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).

Treatment:

Drug: Tramadol

Drug: Hydrocodone

Drug: Oxycodone