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

Phase 2

Active, not recruiting

• Conditions: Intra-abdominal Cancer
• Interventions: Drug: Hydrocodone; Drug: Tramadol; Drug: Oxycodone

• Registration Number: NCT06232577
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Study Start: 2024-03-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5x-Multiplier Model	Tramadol	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.
3-Tier Model	Hydrocodone	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).
5x-Multiplier Model	Hydrocodone	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.
5x-Multiplier Model	Oxycodone	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.
3-Tier Model	Tramadol	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).
3-Tier Model	Oxycodone	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).

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States