Opioid Misuse and AddictionPhase 4NCT05327777
Toward Zero Prescribed Opioids for Outpatient General Surgery
A Phase 4 study testing Oxycodone and Zero Opioid Protocol in people with Opioid Misuse and Addiction and Pain, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Investigators have created an opioid reduction "package" which includes patient education, non-narcotic pain control instructions, and limited (or no) opioid pain prescriptions provided at discharge in an attempt to reduce the number of opioid consumption after outpatient general surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Misuse and Addiction, Pain
- What is being tested?
- Oxycodone and Zero Opioid Protocol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 15 Mar 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Opioid naïve patients
- Age > 18
- Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy
Who cannot join
- Urgent/emergent status
- Previous cholecystostomy tube placement
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Toward Zero Prescribed Opioids for Outpatient General Surgery Procedures: a Prospective Cohort Trial
Investigators have created an opioid reduction "package" which includes patient education, non-narcotic pain control instructions, and limited (or no) opioid pain prescriptions provided at discharge in an attempt to reduce the number of opioid consumption after outpatient general surgery.
Read the detailed description
Between November 2019 and July 2021, patients undergoing elective inguinal hernia repair (IHR) or cholecystectomy were enrolled in the study. Patients were divided into three cohorts: Control, opioid sparing (OS), or zero-opioid (ZO). Control patients did not have any intervention; OS patients had an opioid reduction intervention protocol applied (patient education and perioperative multimodal analgesia) and were provided an opioid prescription at discharge; the ZO had the same protocol, however patients were not provided opioid prescriptions at discharge. Two weeks after discharge patients were interviewed to record opioid consumption, pain scores, and level of satisfaction since discharge.
- Conditions
- Opioid Misuse and Addiction, Pain
- Being tested
- Oxycodone, Zero Opioid Protocol
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Investigators provided set opioid prescriptions for 10 pills each patient.
Zero Opioid ProtocolBehavioural
Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Normal standard practices |
| Opioid Sparing | Experimental | Providers required to prescribe 10 narcotic pills only Receives: Drug: Oxycodone |
| Zero Opioid | Experimental | No narcotic prescription is provided to patient at discharge Receives: Behavioral: Zero Opioid Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Milligram Equivalents Taken by Participants
Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals
Measured: 14 days
Secondary outcomes (1)
Satisfaction Scores Ranging From 1 - 10
Patient will be asked to rank their satisfaction scores on a scale from 1 - 10 (with 1 being extremely dissatisfied and 10 being extremely satisfied) since discharge from the hospital
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Nov 2019
- Primary completion30 Jul 2021
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Misuse and AddictionStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Control group, opioid sparing arm, and zero opioid arm
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Palazzo, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327777
- Sponsor's protocol ID
- 19D.688
- Status last verified
- Jun 2023
- First submitted
- 1 Apr 2022
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No Plans to share the IPD
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward Zero Prescribed Opioids for Outpatient General Surgery Procedures: a Prospective Cohort Trial
- ClinicalTrials.gov ID
- NCT05327777
- Acronym / sponsor ID
- 19D.688
- Conditions
- Opioid Misuse and Addiction, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Posted 5 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators have created an opioid reduction "package" which includes patient education, non-narcotic pain control instructions, and limited (or no) opioid pain prescriptions provided at discharge in an attempt to reduce the number of opioid consumption after outpatient general surgery.
Detailed description
Between November 2019 and July 2021, patients undergoing elective inguinal hernia repair (IHR) or cholecystectomy were enrolled in the study. Patients were divided into three cohorts: Control, opioid sparing (OS), or zero-opioid (ZO). Control patients did not have any intervention; OS patients had an opioid reduction intervention protocol applied (patient education and perioperative multimodal analgesia) and were provided an opioid prescription at discharge; the ZO had the same protocol, however patients were not provided opioid prescriptions at discharge. Two weeks after discharge patients were interviewed to record opioid consumption, pain scores, and level of satisfaction since discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Control group, opioid sparing arm, and zero opioid arm
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Normal standard practices |
| Opioid Sparing | Experimental | Drug: OxycodoneProviders required to prescribe 10 narcotic pills only |
| Zero Opioid | Experimental | Behavioral: Zero Opioid ProtocolNo narcotic prescription is provided to patient at discharge |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Opioid naïve patients
- Age > 18
- Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy
Key exclusion criteria (2 listed)
- Urgent/emergent status
- Previous cholecystostomy tube placement
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 |
|---|---|---|
| OxycodoneInvestigators provided set opioid prescriptions for 10 pills each patient. | Drug | Opioid Sparing |
| Zero Opioid ProtocolInvestigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control. | Behavioural | Zero Opioid |
Primary outcome
Morphine Milligram Equivalents Taken by Participants
Time frame: 14 days
Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals
1 secondary outcome
Satisfaction Scores Ranging From 1 - 10
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No Plans to share the IPD
Related trials for Opioid Misuse and Addiction
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Pain Self-Management and Treatment Engagement for Patients Taking Opioids
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.
Francesco Palazzo, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone and Zero Opioid Protocol in people with Opioid Misuse and Addiction and Pain, run by Thomas Jefferson University 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 3 inclusion and 2 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 5 Jun 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Morphine Milligram Equivalents Taken by Participants (time frame: 14 days). 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 5 Jun 2023.