No Opioids PrescrIptions On Discharge After Surgery

Not Applicable

Completed

• Conditions: Prescription Drug Abuse and Dependency; Opioid Use; Surgery; Postoperative Pain
• Interventions: Behavioral: No opioids at discharge

• Registration Number: NCT04469868
• Lead Sponsor: Albany Medical College

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.

Study Timeline

• Study Start: 2018-12-15
• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-14
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No opioids prescriptions at discharge	No opioids 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.

Primary Outcome Measures

Name	Time	Method
Opioids prescribing at hospital discharge	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	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 Outcome Measures

Name	Time	Method
Contact with healthcare facilities	30 days	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.
Post-operative pain after discharge	7 days	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	7 days	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.

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States