No Opioids PrescrIptions On Discharge After Surgery

NCT ID: NCT04469868

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-15

Study Completion Date

2024-04-01

Brief Summary

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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

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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.

Conditions

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Opioid Use Prescription Drug Abuse and Dependency Surgery Postoperative Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

PREVENTION

Blinding Strategy

NONE

Study Groups

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No opioids prescriptions at discharge

Patients will receive non-opioid analgesia, mostly over the counter, medications such as acetaminophen or ibuprofen. Opioids may be prescribed if the patients experience break through pain and call the office.

Group Type EXPERIMENTAL

No opioids at discharge

Intervention Type BEHAVIORAL

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.

Interventions

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No 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albany Medical College

OTHER

Sponsor Role lead

Responsible Party

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Badar M. Mian

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Badar Mian, MD

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Locations

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Albany Medical Center

Albany, New York, United States

Site Status

Countries

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United States

Other Identifiers

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5866

Identifier Type: -

Identifier Source: org_study_id

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