Toward Zero Prescribed Opioids for Outpatient General Surgery

NCT ID: NCT05327777

Last Updated: 2023-06-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2023-03-15

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.

Conditions

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Opioid Misuse and Addiction Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Control group, opioid sparing arm, and zero opioid arm
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Normal standard practices

Group Type NO_INTERVENTION

No interventions assigned to this group

Opioid Sparing

Providers required to prescribe 10 narcotic pills only

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

Investigators provided set opioid prescriptions for 10 pills each patient.

Zero Opioid

No narcotic prescription is provided to patient at discharge

Group Type EXPERIMENTAL

Zero Opioid Protocol

Intervention Type BEHAVIORAL

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

Interventions

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Oxycodone

Investigators provided set opioid prescriptions for 10 pills each patient.

Intervention Type DRUG

Zero Opioid Protocol

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco Palazzo, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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19D.688

Identifier Type: -

Identifier Source: org_study_id

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