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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Normal standard practices | |
| Opioid Sparing | Experimental | Providers required to prescribe 10 narcotic pills only |
|
| Zero Opioid | Experimental | No narcotic prescription is provided to patient at discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | Investigators provided set opioid prescriptions for 10 pills each patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Palazzo, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
No Plans to share the IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Normal standard practices |
| FG001 | Opioid Sparing | Providers required to prescribe 10 narcotic pills only Oxycodone: Investigators provided set opioid prescriptions for 10 pills each patient. |
| FG002 | Zero Opioid | No narcotic prescription is provided to patient at discharge Zero Opioid Protocol: Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Normal standard practices |
| BG001 | Opioid Sparing | Providers required to prescribe 10 narcotic pills only Oxycodone: Investigators provided set opioid prescriptions for 10 pills each patient. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Inter-Quartile Range | morphine milligram equivalents | 14 days |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Normal standard practices | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Resident | Thomas Jefferson University Hospital | 516-547-7676 | ryan.lamm@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2019 | Jun 1, 2023 | Prot_SAP_004.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D016739 | Behavior, Addictive |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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Control group, opioid sparing arm, and zero opioid arm
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| Zero Opioid Protocol | Behavioral | Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control. |
|
| BG002 | Zero Opioid | No narcotic prescription is provided to patient at discharge Zero Opioid Protocol: Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
No narcotic prescription is provided to patient at discharge Zero Opioid Protocol: Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control. |
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | units on a scale | 14 days |
|
|
|
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Opioid Sparing | Providers required to prescribe 10 narcotic pills only Oxycodone: Investigators provided set opioid prescriptions for 10 pills each patient. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG002 | Zero Opioid | No narcotic prescription is provided to patient at discharge Zero Opioid Protocol: Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |