No Opioids PrescrIptions On Discharge After Surgery (NOPIOiDS)
Primary Purpose
Opioid Use, Prescription Drug Abuse and Dependency, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No opioids at discharge
Sponsored by
About this trial
This is an interventional prevention trial for Opioid Use focused on measuring Opioids, Prescriptions, Surgery, Recovery, Pain score
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.
Sites / Locations
- Albany Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
No opioids prescriptions at discharge
Arm Description
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.
Outcomes
Primary Outcome Measures
Opioids prescribing at hospital discharge
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
The electronic medical records and pharmacy records will be monitored to identify if any additional opioids prescriptions were provided by any provider
Secondary Outcome Measures
Post-operative pain after discharge
Visual 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 recovery
Overall 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 facilities
All 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04469868
Brief Title
No Opioids PrescrIptions On Discharge After Surgery
Acronym
NOPIOiDS
Official Title
Prospective Study of No Opioids PrescrIptions On Discharge After Surgery (NOPIOiDS)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2018 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Prescription Drug Abuse and Dependency, Surgery, Postoperative Pain
Keywords
Opioids, Prescriptions, Surgery, Recovery, Pain score
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients who undergo major urologic oncology surgery will be eligible to be enrolled.
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No opioids prescriptions at discharge
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No opioids at discharge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioids prescribing at hospital discharge
Description
Patients will be discharged with no or few opioids after surgery along with instruction on how to use non-opioid analgesic measures.
Time Frame
30 days
Title
All opioids prescriptions within 30 days of surgery
Description
The electronic medical records and pharmacy records will be monitored to identify if any additional opioids prescriptions were provided by any provider
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Post-operative pain after discharge
Description
Visual 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.
Time Frame
7 days
Title
Satisfaction score during home recovery
Description
Overall 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.
Time Frame
7 days
Title
Contact with healthcare facilities
Description
All 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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Badar M. Mian, MD
Phone
515-262-7558
Email
mianb@amc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Badar Mian, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Badar M. Mian, MD
Phone
518-262-7558
Email
mianb@amc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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No Opioids PrescrIptions On Discharge After Surgery
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