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No Opioids PrescrIptions On Discharge After Surgery

Prospective Study of No Opioids PrescrIptions On Discharge After Surgery (NOPIOiDS)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04469868
Acronym
NOPIOiDS
Enrollment
350
Registered
2020-07-14
Start date
2018-12-15
Completion date
2024-04-01
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Postoperative Pain, Prescription Drug Abuse and Dependency, Surgery

Keywords

Opioids, Prescriptions, Surgery, Recovery, Pain score

Brief summary

Opioid analgesics are routinely prescribed for these patients for post-operative pain control. Even a short exposure to opioids in opioid-naïve patients following minor or major surgery has been associated with de novo habitual or persistent use of opioids in 5-30% of patients. The goal of the study to eliminate the use of outpatient opioids prescriptions after major urologic surgery.

Detailed description

Nearly 200 million opioid prescriptions are dispensed per year in the United States. Opioid prescriptions given by medical providers are a major contributor to the opioid abuse epidemic. Nearly 40% of opioid overdose-related deaths occur due to prescribed opioids. Among patients diagnosed with opiate dependence, 80% had received an opioid prescription prior to their abuse diagnosis and 51% had a family member who had an opioid prescription, Thus, opioids prescriptions, which are often in excess of the need by the patient, are a major contributor to this public health crisis. The investigators devised a prospective intervention study to eliminate or significantly reduced the use of opioids prescribed at hospital discharge after major urologic surgery.

Interventions

BEHAVIORALNo opioids at discharge

Patients who are being scheduled for any major urologic cancer surgery (open or laparoscopic) will be counselled regarding post-operative pain and measures taken during surgery and during hospital stay. They will be provided written information on these pain mitigation efforts and the adverse effects associated with opioids use and outpatient prescriptions. Patients will be discharged from the hospital without any opioids prescriptions and instructions to use non-opioids analgesics. Patients will complete a visual analog pain scale daily for 7 days after discharge from the hospital. Patients will be able to call the clinic at anytime for any post-operative pain issues.

Sponsors

Albany Medical College
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

All patients who undergo major urologic oncology surgery will be eligible to be enrolled.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients undergoing major urologic cancer surgery, either open or laparoscopic, will be included in the study. * This will include all open or laparoscopic or robotic surgery including radical prostatectomy, radical cystectomy, radical nephrectomy, partial nephrectomy, nephron-ureterectomy, and similar procedures.

Exclusion criteria

* Those with allergy or intolerance to NSAIDS may be excluded.

Design outcomes

Primary

MeasureTime frameDescription
Opioids prescribing at hospital discharge30 daysPatients will be discharged with no or few opioids after surgery along with instruction on how to use non-opioid analgesic measures.
All opioids prescriptions within 30 days of surgery30 daysThe electronic medical records and pharmacy records will be monitored to identify if any additional opioids prescriptions were provided by any provider

Secondary

MeasureTime frameDescription
Post-operative pain after discharge7 daysVisual analog pain scale (which ranges from 0-10) will be completed daily for 7 days. Score of zero signifies no pain at all and a a score of 10 implies the worst pain ever experienced.
Satisfaction score during home recovery7 daysOverall satisfaction score (0-100%) with post-operative pain, discomfort and recovery at home. A higher score signifies more satisfaction with pain control during the recovery process.
Contact with healthcare facilities30 daysAll phone calls to the clinic, unplanned visits, emergency room visits, hospital admissions will recorded and combined as a single measure of contact with any healthcare facility as a measure of resource utilization.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026