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Opioid

Opioid Prescriptions for Abdominal Cancer Surgery

Phase 2

Recruiting

Led By Ching-Wei D Tzeng, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with a planned inpatient admission of at least 48 hours after surgery

Open nephrectomy

Must not have

Participants unable or unwilling to participate in follow-up study requirements (e.g., QOL surveys, opioid log)

Participants requiring >7.5 mg OME per day (on average) during the 30 days prior to surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two different ways of prescribing opioid pain medication to help patients with abdominal cancer manage pain after surgery.

Who is the study for?

This trial is for adults over 18 who have abdominal cancer and are undergoing specific open surgeries like pancreatectomy or hepatectomy. They must be opioid-naive, using less than or equal to 7.5 mg of opioids daily, and expected to stay in the hospital for at least two days post-surgery. Participants must understand and sign a consent form; both English and non-English speakers can join.

What is being tested?

The study is testing two methods of prescribing opioid painkillers—Hydrocodone, Tramadol, Oxycodone—after abdominal cancer surgery. The goal is to see which model offers better pain control: the '5x-Multiplier' approach versus the '3-Tier Model'.

What are the potential side effects?

Possible side effects from Hydrocodone, Tramadol, Oxycodone include nausea, vomiting, constipation, drowsiness, dizziness, itching skin reactions and potential dependency or withdrawal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will be staying in the hospital for at least 2 days after my surgery.

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I have had or will have an open surgery to remove a kidney.

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I have had open surgery to reduce my ovarian cancer.

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I use very little or no opioid pain medication daily.

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I use less than or equal to 7.5 mg of opioids daily.

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I am scheduled for or have had an open surgery on my pancreas.

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I am scheduled for or have had an open liver surgery.

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I had surgery to remove a tumor from behind my abdomen.

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I am 18 years old or older.

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I am scheduled for a specific abdominal surgery at MD Anderson.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing and able to follow the study's follow-up requirements.

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I have been taking more than 7.5 mg of opioid medication daily for the last month.

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I am currently receiving palliative or hospice care.

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I need surgery soon for an urgent health issue.

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I am using hydromorphone or fentanyl, or I am under the care of a chronic pain specialist.

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I am on long-term pain medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 5x-Multiplier ModelExperimental Treatment3 Interventions

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.

Group II: 3-Tier ModelExperimental Treatment3 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydrocodone

2016

Completed Phase 4

~27680

Tramadol

2014

Completed Phase 4

~3320