No Opioids PrescrIptions On Discharge After Surgery

NCT04469868 | Completed

• 1 other identifier: 5866
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Prescription Drug Abuse and Dependency; Surgery; Postoperative Pain

Keywords

Opioids; Prescriptions; Surgery; Recovery; Pain score

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Post-operative pain after discharge

  7 days

• Satisfaction score during home recovery

  7 days

• Contact with healthcare facilities

  30 days

Study Arms (1)

No opioids prescriptions at discharge

EXPERIMENTAL

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

Interventions

No opioids at discharge 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.

No opioids prescriptions at discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those with allergy or intolerance to NSAIDS may be excluded.

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Badar Mian, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: All patients who undergo major urologic oncology surgery will be eligible to be enrolled.

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 14, 2020
• Study Start: December 15, 2018
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)