Skip to main content
OpenTrials
Completed

NCT Number: NCT05327777

Toward Zero Prescribed Opioids for Outpatient General Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Misuse and Addiction Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Impulsive Behavior Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

Investigators provided set opioid prescriptions for 10 pills each patient.

Zero Opioid Protocol

Behavioral

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

Primary outcomes

  1. Morphine Milligram Equivalents Taken by Participants

    Time frame: 14 days

    Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals

Secondary outcomes

  1. Satisfaction Scores Ranging From 1 - 10

    Time frame: 14 days

    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

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Apr 14, 2022
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.