Opioid UseNOPIOiDSNCT04469868
No Opioids PrescrIptions On Discharge After Surgery
A study testing No opioids at discharge in people with Opioid Use and Prescription Drug Abuse and Dependency, run by Albany Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Prescription Drug Abuse and Dependency, Surgery
- What is being tested?
- No opioids at discharge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2018to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those with allergy or intolerance to NSAIDS may be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- No opioids at discharge
- Keywords
- Opioids, Prescriptions, Surgery, Recovery, Pain score
- Medical subject headings
- Substance-Related Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No opioids at dischargeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: No opioids at discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 30 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start15 Dec 2018
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients who undergo major urologic oncology surgery will be eligible to be enrolled.
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Badar M. Mian, Albany Medical College
- Investigators
- Badar Mian, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469868
- Sponsor's protocol ID
- 5866
- Acronym
- NOPIOiDS
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2020
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of No Opioids PrescrIptions On Discharge After Surgery (NOPIOiDS)
- ClinicalTrials.gov ID
- NCT04469868
- Acronym / sponsor ID
- NOPIOiDS / 5866
- Keywords
- Opioids, Prescriptions, Surgery, Recovery, Pain score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients who undergo major urologic oncology surgery will be eligible to be enrolled.
| Arm | Type | Receives |
|---|---|---|
| No opioids prescriptions at discharge | Experimental | Behavioral: No opioids at dischargePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Those with allergy or intolerance to NSAIDS may be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No opioids at dischargePatients 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. | Behavioural | No opioids prescriptions at discharge |
Primary outcome
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.
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
3 secondary outcomes
Post-operative pain after discharge
Time frame: 7 days
Satisfaction score during home recovery
Time frame: 7 days
Contact with healthcare facilities
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Badar Mian, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No opioids at discharge in people with Opioid Use and Prescription Drug Abuse and Dependency, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioids prescribing at hospital discharge (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.