A Phase 4 interventional study of Oxycodone and Zero Opioid Protocol in Opioid Misuse and Addiction and Pain, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by Thomas Jefferson University · Phase 4, Interventional, and Prevention
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 129 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Normal standard practices
Providers required to prescribe 10 narcotic pills only
Drug: Oxycodone
No narcotic prescription is provided to patient at discharge
Behavioral: Zero Opioid Protocol
Investigators provided set opioid prescriptions for 10 pills each patient.
Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.
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
Time frame: 14 days
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
Time frame: 14 days
| Milestone | Control | Opioid Sparing | Zero Opioid |
|---|---|---|---|
| Started | 58 | 42 | 29 |
| Completed | 58 | 42 | 29 |
| Not completed | 0 | 0 | 0 |
Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals
| morphine milligram equivalents | Control | Opioid Sparing | Zero Opioid |
|---|---|---|---|
| Morphine Milligram Equivalents Taken by Participants | 46 (37.5 to 75) | 15 (11 to 22.5) | 0 (0 to 0) |
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
| units on a scale | Control | Opioid Sparing | Zero Opioid |
|---|---|---|---|
| Satisfaction Scores Ranging From 1 - 10 | 10 (9 to 10) | 10 (9 to 10) | 10 (8.5 to 10) |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/58 (0%) | 0/58 (0%) | 0/58 (0%) |
| Opioid Sparing | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Zero Opioid | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Age, Continuous(years) | Control | Opioid Sparing | Zero Opioid | Total |
|---|---|---|---|---|
| Mean | 52.4 ± 1.8 | 55.3 ± 2.0 | 58.6 ± 2.9 | 54 ± 3.4 |
| Sex: Female, Male(Participants) | Control | Opioid Sparing | Zero Opioid | Total |
|---|---|---|---|---|
| Female | 19 | 10 | 2 | 31 |
| Male | 39 | 32 | 27 | 98 |
| Race (NIH/OMB)(Participants) | Control | Opioid Sparing | Zero Opioid | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 2 | 1 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 7 | 15 |
| White | 47 | 31 | 22 | 100 |
| More than one race | 5 | 4 | 0 | 9 |
| Unknown or Not Reported | 1 | 1 | 0 | 2 |
| Region of Enrollment(participants) | Control | Opioid Sparing | Zero Opioid | Total |
|---|---|---|---|---|
| United States | 58 | 42 | 29 | 129 |
| BMI(kg/m^2) | Control | Opioid Sparing | Zero Opioid | Total |
|---|---|---|---|---|
| Median | 27.8 (25.4 to 32.1) | 27.9 (24.3 to 31) | 25.4 (23.3 to 28.7) | 27 (25 to 30) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No Plans to share the IPD
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University