No Opioids PrescrIptions On Discharge After Surgery (NOPIOiDS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Surgery; Opioid Use; Prescription Drug Abuse and Dependency
• Intervention / Treatment: Behavioral: No opioids at discharge

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.

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Badar M. Mian, MD; Phone Number: 515-262-7558; Email: mianb@amc.edu

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center
      • Contact: Badar M. Mian, MD; Phone Number: 518-262-7558; Email: mianb@amc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days
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.	7 days
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.	30 days

Collaborators and Investigators

• Sponsor: Albany Medical College
• Investigators: Principal Investigator: Badar Mian, MD, Albany Medical College

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2018
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Recovery; Surgery; Opioids; Prescriptions; Pain score
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 5866

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No