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Trial Title:
5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial
NCT ID:
NCT06232577
Condition:
Intra-abdominal Cancer
Conditions: Official terms:
Abdominal Neoplasms
Oxycodone
Tramadol
Hydrocodone
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hydrocodone
Description:
Given by PO
Arm group label:
3-Tier Model
Arm group label:
5x-Multiplier Model
Intervention type:
Drug
Intervention name:
Tramadol
Description:
Given by PO
Arm group label:
3-Tier Model
Arm group label:
5x-Multiplier Model
Intervention type:
Drug
Intervention name:
Oxycodone
Description:
Given by PO
Arm group label:
3-Tier Model
Arm group label:
5x-Multiplier Model
Other name:
ETH-Oxydose™ [DSC]
Other name:
OxyContin®
Other name:
OxyIR®
Other name:
Roxicodone®
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ching-Wei D Tzeng, MD
Phone:
713-792-0386
Email:
cdtzeng@mdanderson.org
Investigator:
Last name:
Ching-Wei D Tzeng, MD
Email:
Principal Investigator
Start date:
March 27, 2024
Completion date:
July 1, 2026
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06232577
http://www.mdanderson.org
