Back to resultsToward Zero Prescribed Opioids for Outpatient General Surgery
Primary Purpose
Opioid Misuse and Addiction, Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Zero Opioid Protocol
Sponsored by
About this trial
This is an interventional prevention trial for Opioid Misuse and Addiction
Eligibility Criteria
Inclusion Criteria:
- Opioid naïve patients
- Age > 18
- Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy
Exclusion Criteria:
- Urgent/emergent status
- Previous cholecystostomy tube placement
Sites / Locations
- Thomas Jefferson University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Opioid Sparing
Zero Opioid
Arm Description
Normal standard practices
Providers required to prescribe 10 narcotic pills only
No narcotic prescription is provided to patient at discharge
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05327777
First Posted
April 1, 2022
Last Updated
June 2, 2023
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT05327777
Brief Title
Toward Zero Prescribed Opioids for Outpatient General Surgery
Official Title
Toward Zero Prescribed Opioids for Outpatient General Surgery Procedures: a Prospective Cohort Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
March 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Misuse and Addiction, Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Control group, opioid sparing arm, and zero opioid arm
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Normal standard practices
Arm Title
Opioid Sparing
Arm Type
Experimental
Arm Description
Providers required to prescribe 10 narcotic pills only
Arm Title
Zero Opioid
Arm Type
Experimental
Arm Description
No narcotic prescription is provided to patient at discharge
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Investigators provided set opioid prescriptions for 10 pills each patient.
Intervention Type
Behavioral
Intervention Name(s)
Zero Opioid Protocol
Intervention Description
Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.
Primary Outcome Measure Information:
Title
Morphine Milligram Equivalents Taken by Participants
Description
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
Secondary Outcome Measure Information:
Title
Satisfaction Scores Ranging From 1 - 10
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Opioid naïve patients
Age > 18
Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy
Exclusion Criteria:
Urgent/emergent status
Previous cholecystostomy tube placement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Palazzo, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No Plans to share the IPD
Learn more about this trial
Toward Zero Prescribed Opioids for Outpatient General Surgery
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