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

Phase 2Active Not RecruitingNCT06232577

M.D. Anderson Cancer Center170 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

170

Conditions

Intra-abdominal Cancer

Interventions

HydrocodoneDRUG

Given by PO

TramadolDRUG

Given by PO

OxycodoneDRUG

Given by PO

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Safety and adverse events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame: Through study completion; an average of 1 year

Data from ClinicalTrials.gov

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