Toward Zero Prescribed Opioids for Outpatient General Surgery

NCT05327777 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 19D.688
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Misuse and Addiction; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Satisfaction Scores Ranging From 1 - 10

  14 days

Study Arms (3)

Control

NO INTERVENTION

Normal standard practices

Opioid Sparing

EXPERIMENTAL

Providers required to prescribe 10 narcotic pills only

Drug: Oxycodone

Zero Opioid

EXPERIMENTAL

No narcotic prescription is provided to patient at discharge

Behavioral: Zero Opioid Protocol

Interventions

Oxycodone DRUG

Investigators provided set opioid prescriptions for 10 pills each patient.

Opioid Sparing

Zero Opioid Protocol BEHAVIORAL

Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.

Zero Opioid

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Opioid naïve patients
• Age \> 18
• Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy

You may not qualify if:

• Urgent/emergent status
• Previous cholecystostomy tube placement

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive; Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Research Resident
• Organization: Thomas Jefferson University Hospital

ryan.lamm@jefferson.edu

516-547-7676

Study Officials

• Francesco Palazzo, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group, opioid sparing arm, and zero opioid arm

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 14, 2022
• Study Start: November 1, 2019
• Primary Completion: July 30, 2021
• Study Completion: March 15, 2023
• Last Updated: June 5, 2023
• Results First Posted: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)