Toward Zero Prescribed Opioids for Outpatient General Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Toward Zero Prescribed Opioids for Outpatient General Surgery Procedures: a Prospective Cohort Trial

Conditions
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Opioid Misuse and Addiction, Pain

Intervention / Treatment
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* Drug: Oxycodone
* Behavioral: Zero Opioid Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control group, opioid sparing arm, and zero opioid arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Normal standard practices | |
| Experimental: Opioid Sparing<br>Providers required to prescribe 10 narcotic pills only | Drug: Oxycodone<br>* Investigators provided set opioid prescriptions for 10 pills each patient.<br>|
| Experimental: Zero Opioid<br>No narcotic prescription is provided to patient at discharge | Behavioral: Zero Opioid Protocol<br>* Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |