Opioid Sparing Pain Management Strategy

Sponsor
Prisma Health-Upstate (Other)
Overall Status
Completed
CT.gov ID
NCT04269109
Collaborator
(none)
150
Enrollment
1
Location
30
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Multi-modal Opioid Sparing Pain Management Protocol

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Multi-modal, Opioid Sparing Pain Management Strategy in Cardiac Surgery
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Apr 30, 2019
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Control Cohort

A control cohort from September 1, 2018 - October 31, 2018

Other: Multi-modal Opioid Sparing Pain Management Protocol
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.

Intervention Cohort

An intervention cohort from March 1, 2019 - April 30, 2019

Other: Multi-modal Opioid Sparing Pain Management Protocol
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.

Outcome Measures

Primary Outcome Measures

  1. Morphine Milligram Equivalents Comparison [1 year]

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

Secondary Outcome Measures

  1. Ileus [1 year]

    Compare incidence of postoperative ileus between both cohorts.

  2. Delirium [1 year]

    Compare incidence of delirium between both cohorts.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Prisma Health-UpstateGreenvilleSouth CarolinaUnited States29605

Sponsors and Collaborators

  • Prisma Health-Upstate

Investigators

  • Principal Investigator: Caroline McKillop, MD, Prisma Health-Upstate

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Prisma Health-Upstate
ClinicalTrials.gov Identifier:
NCT04269109
Other Study ID Numbers:
  • Pro00085849
First Posted:
Feb 13, 2020
Last Update Posted:
Apr 13, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2021