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Completed

NCT Number: NCT04269109

Opioid Sparing Pain Management Strategy

The purpose of this research study is to compare the amount of morphine milligram equivalents consumed post operatively until discharge between the control cohort and intervention cohort.

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Key information

Conditions

Cardiac Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prisma Health-Upstate

Greenville, South Carolina, 29605, United States

About this study

Retrospective data will be collected on patients admitted to Prisma Health-Upstate Greenville Memorial Hospital in the Cardiovascular Intensive Care Unit following cardiovascular surgery. They will be divided into two cohorts, a control cohort from September 1, 2018 - October 31, 2018 and an intervention cohort from March 1, 2019 - April 30, 2019. A study investigator will assess each participant's electronic medical record through the electronic medical record database - EPIC to determine eligibility per the protocol. Demographic information will be collected, including age, date of birth, race, sex, height, weight, and ethnicity. Extubation and reintubation status will be collected along with medical history, type of cardiovascular procedure, medications, length of stay, pain scores, complications, and labs.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patients 18 and over
  • Patients who underwent cardiac surgery requiring a coronary pulmonary bypass machine during September 1, 2018 - April 30, 2019

Exclusion criteria

  • Patients being placed on Extracorporeal Membrane Oxygenation

Treatment and study plan

Multi-modal Opioid Sparing Pain Management Protocol

Other

Incorporating multimodal opioid sparing ERAS techniques for cardiac surgery patients should show a decrease in the amount of opioids received, reduction in incidence of chronic pain, ileus, delirium, and potential for opioid addiction post-operatively. Between the dates of November 2018 through February 2019, a multi-modal, opioid sparing pain management protocol was evolving and a protocol was put into place. This study will compare outcomes before and after implementation of the protocol between the dates of September 1, 2018 - October 31, 2018 and March 1, 2019 - April 30, 2019.

Primary outcomes

  1. Morphine Milligram Equivalents Comparison

    Time frame: 1 year

    Compare the amount of morphine milligram equivalents consumed post operatively until discharge between groups.

Secondary outcomes

  1. Ileus

    Time frame: 1 year

    Compare incidence of postoperative ileus between both cohorts.

  2. Delirium

    Time frame: 1 year

    Compare incidence of delirium between both cohorts.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Official study title

A Multi-modal, Opioid Sparing Pain Management Strategy in Cardiac Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Feb 13, 2020
Registry last updated
Apr 13, 2021

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.

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