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Completed

NCT Number: NCT04469868

No Opioids PrescrIptions On Discharge After Surgery

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.

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Key information

Conditions

Opioid Use Chemically-Induced Disorders Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Prescription Drug Abuse and Dependency Signs and Symptoms Substance-Related Disorders Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albany Medical Center

Albany, New York, 12208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Opioids prescribing at hospital discharge

    Time frame: 30 days

    Patients will be discharged with no or few opioids after surgery along with instruction on how to use non-opioid analgesic measures.

  2. All opioids prescriptions within 30 days of surgery

    Time frame: 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 outcomes

  1. Post-operative pain after discharge

    Time frame: 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.

  2. Satisfaction score during home recovery

    Time frame: 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.

  3. Contact with healthcare facilities

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Official study title

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

Acronym: NOPIOiDS

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2020
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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