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Clinical Trials/NCT04469868
NCT04469868
Completed
N/A

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

Albany Medical College1 site in 1 country350 target enrollmentDecember 15, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Opioid Use
Sponsor
Albany Medical College
Enrollment
350
Locations
1
Primary Endpoint
Opioids prescribing at hospital discharge
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2018
End Date
April 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Badar M. Mian

Professor of Surgery

Albany Medical College

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Opioids prescribing at hospital discharge

Time Frame: 30 days

Patients 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 surgery

Time Frame: 30 days

The electronic medical records and pharmacy records will be monitored to identify if any additional opioids prescriptions were provided by any provider

Secondary Outcomes

  • Contact with healthcare facilities(30 days)
  • Post-operative pain after discharge(7 days)
  • Satisfaction score during home recovery(7 days)

Study Sites (1)

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