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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status and phase

Enrolling
Phase 2

Conditions

Intra-abdominal Cancer

Treatments

Drug: Tramadol
Drug: Oxycodone
Drug: Hydrocodone

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. 1. To determine OME usage by day 14 after hospital discharge. Secondary Objectives: Secondary objectives are as follows: To determine rates of patients with zero OME upon discharge. To determine rates of OME refill requests and completions at 15- and 30-days post-operation. To determine number of unused or leftover pills at 15- and 30-days post- operation To determine persistent opioid use at 30-days, 3-months, and 6-months post-operation To elucidate patient, prescriber, and oncologic factors predictive of persistent opioid use To assess quality of life using patient-reported outcomes at 30-days, 3-months, and 6-months post-operation. 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: Hydrocodone
Drug: Oxycodone
Drug: Tramadol
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: Hydrocodone
Drug: Oxycodone
Drug: Tramadol

Trial contacts and locations

1

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Central trial contact

Ching-Wei D Tzeng, MD

Data sourced from clinicaltrials.gov

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